Policy and Procedure Manual

Transcription

1 Policy and Procedure Manual Diagnostic Services Radiology DS-R SUBJECT/TITLE: PURPOSE: INTRAVENOUS CONTRAST ADMINISTRATION 1) Ensure appropriate premedication in patients with known/suspected allergic reactions; 2) Ensure contrast administration is performed according to hospital and departmental protocols with appropriate supervision by a licensed independent practitioner (LIP). 3) Ensure appropriate actions are undertaken in case of contrast reactions and extravasation of contrast. 4) Ensure laboratory testing requirements conducted in patients in whom contrast administration is considered. DEFINITION: BACKGROUND: None The policy will be based on the Manual on Contrast Media (ACR, 2012) and other relevant literature. CONTENTS: A. Intravenous Iodinated Contrast Preparation for Contrast Administration Indications for Serum Creatinine Contrast Reactions to Iodinated IV Contrast Premedication for Iodinated IV contrast B. Intravenous Gadolinium Based Contrast Administration of Gadolinium Magnetic Resonance (MR) Screening for Impaired Renal Function Emergency MR Exams Premedication for Gadolinium contrast C. Intra-arterial Iodinated Contrast Administration D. Non-Intravenous Contrast Agents E. Ultrasound Contrast Agents F. Pediatric IV Contrast Administration G. Treatment of Contrast Reaction Table 1: Suggested Treatments for Contrast Reaction H. Treatment and Prevention of Contrast Extravasation I. Pregnancy and Breast Feeding Precautions J. Appendix A: Patient Information Sheet for Contrast Enhanced MRI K. Appendix B: Patient information Sheet for Breast Feeding after Contrast Enhanced MRI

2 POLICY: Guidelines for administration of Intravenous contrast: 1. A radiologic technologist or radiology nurse may administer intravenous contrast under the supervision of a licensed independent practitioner (LIP) and in accordance with procedure defined in this policy and following protocols used for contrast administration that are based upon the type of examination ordered and define the type, dose and route of contrast. 2. The supervising LIP or his/her physician designee must be available to respond promptly to an adverse event related to contrast administration. 3. Protocols for administration of intravenous contrast must be reviewed by the Department of Pharmaceutical Care Drug Information Center and approved by the P&T Subcommittee and by the Contrast Committee of the Department of Radiology when the standards of care and application change or when the characteristics of the intravenous contrast change. 4. An LIP reviews all requests for radiology procedures with intravenous contrast to determine and/or modify the appropriate protocol based on the clinical indications for the examination and patient status. The assigned protocol is indicated in the radiology information system (RIS) or electronic medical record (EMR). 5. A radiologic technologist or radiology nurse will review patient s current medications and clinical conditions for contraindications related to intravenous contrast administration. These include allergy to contrast, use of particular medications (e.g., metformin see below), and general physical condition which may impact risks for patient, such as heart failure and asthma. 6. If contraindications are identified, the supervising LIP will be contacted to determine appropriate IV contrast use. 7. Type of contrast and dose information is recorded in the EMR by the nurse or technologist. 8. Contrast doses that are prepared and NOT immediately administered to patient by the person who prepared the dose must be labeled with: Drug name, strength and amount (if not apparent from container) Initials or name of the person preparing the syringe Name of patient, medical record number, date of birth and location of the patient, if contrast dose is prepared based upon specific patient information. The dose should be used immediately and not stored. Page 2 of 19

3 PROCEDURE: A. INTRAVENOUS IODINATED CONTRAST All intravenous contrast utilized for CT and fluoroscopic exams at UIHC utilize iodine. The differing contrast agents will vary based on the form that the iodine is organically bound. Other variables in the type of iodinated contrast include ionic vs. nonionic, high osmolar (HOCM) vs. low osmolar (LOCM), and iso-osmolar contrast media. Preparation for Contrast Administration 1. Pre-administration Checks (4 Hs) The ACR manual describes the 4 Hs a. History b. Hydration c. Have equipment and expertise ready d. Heads up These checks have an effect on both the need for premedication, the risk of contrast extravasation, and the need for laboratory testing. 2. Renal failure-related issues with iodinated contrast a. Iodinated contrast has been implicated in causing significant decreased renal function in some patients following its administration, an effect called contrast media nephrotoxicity. b. Significant contrast media induced nephrotoxicity may be defined as: a >25% rise in serum creatinine from baseline (if < 1.5 mg/dl) OR an absolute elevation of >1.0 mg/dl from baseline (if > 1.5 mg/dl) within 72 hours following contrast administration. 3. Risk factors for contrast induced renal failure include: a. Pre-existing renal insufficiency b. History of kidney disease as an adult, including tumor and transplant c. Diabetes mellitus d. Dehydration e. Cardiovascular disease and use of diuretics f. Age > 60 years g. Multiple myeloma or paraproteinemia syndromes/diseases h. Uncontrolled Hypertension i. Hyperuricemia (gout) 4. Medications which may increase the risk of iodinated contrast-induced renal failure. a. Metformin (oral hypoglycemic agent for diabetes): This drug is excreted by the kidneys, and may accumulate resulting in severe (even fatal) lactic acidosis. b. NSAIDs including COX-2 selective agents (e.g., ibuprofen, naproxen, ketorolac, fenoprofen, indomethacin, celecoxib, etc.) c. Nephrotoxic antimicrobials (e.g., gentamicin, tobramycin, amikacin, amphotericin B, cidofovir) Page 3 of 19

4 5. Indications for serum creatinine prior to iodinated contrast exam The following patients must have a serum creatinine within 60 days prior to the exam: Age > 60 History of renal disease, including: Dialysis Kidney transplant Single kidney Renal cancer Renal surgery History of hypertension requiring medical therapy History of diabetes mellitus Metformin or metformin-containing drug combinations 6. Measures to Prevention/Ameliorate Nephrotoxicity a. Hydration if required. Normally, this can be achieved by oral administration of 1-2 liters of extra fluids in the 24 hours prior to contrast injection. In some cases, this can be achieved using 0.45% or 0.9% saline, 100 ml/hr from 12 hours before until 12 hours after contrast administration. b. Withhold furosemide. c. Withhold metformin for 48 hours after contrast administration and reinstitute only after repeat renal function tests (creatinine) had been obtained and determined to be normal. d. In patients with risk factors for contrast-induced renal failure, administer acetylcysteine, 600 mg by mouth twice daily on the day before and on the day of contrast administration (4 total doses). e. In patients who present acutely and who have an indication for acetylcysteine in patients with an adynamic ileus or non-intact GI tract, or patients who are unable to swallow and have no NG tube, two options are allowed: No contrast is administered; this is the preferred option for patients who present acutely) In life-threatening situations where a contrast-enhanced CT is required immediately (e.g., suspected pulmonary embolism, suspected aortic dissection, suspected aortic rupture, immediate requirement for vascular intervention), and where a 24-hour delay is unacceptable based on clinical grounds, one may consider administration of IV acetylcysteine (Acetadote 150 mg/kg over 30 minutes immediately prior contrast administration, followed by 50 mg/kg over 4 hours after). If IV acetylcysteine is administered, one must to be prepared for anaphylactic reactions and appropriate precautions much be taken. 7. Patients on Dialysis Patients on dialysis can receive IV contrast, and early post-procedural dialysis is NOT routinely required in every case. The Nephrology Service should be consulted for these cases. The fact that a patient is on dialysis should NOT be regarded as automatically allowing the administration IV contrast. Page 4 of 19

5 CONTRAST REACTIONS TO IODINATED IV CONTRAST Reactions to iodinated IV contrast occur in 1-3% of nonionic low-osmolar contrast injections. These range from mild urticaria (hives) to severe and life-threatening events. The severe lifethreatening reactions are relatively rare. Although overall adverse reactions are decreased following steroid premedication, the incidence of severe life-threatening adverse events has not been affected. Therefore, administration of IV contrast in patients with previous severe reactions should be done only in exceptional circumstances with full agreement by the patient, attending physician(s) and radiologist. 1. Premedication The following regimens are suggested based on the ACR Manual on Contrast media version : a. Planned contrast administration in patients with previous documented/suspected reaction: Two frequently used regimens are: 1. Prednisone 50 mg by mouth at 13 hours, 7 hours, and 1 hour before contrast media injection, plus diphenhydramine (Benadryl ) 50 mg intravenously, intramuscularly, or by mouth 1 hour before contrast medium. or 2. Methylprednisolone (Medrol ) 32 mg by mouth 12 hours and 2 hours before contrast media injection. An antihistamine (as in option 1) can also be added to this regimen injection. If the patient is unable to take oral medication, 200 mg of hydrocortisone intravenously may be substituted for oral prednisone. b. (Semi-) acute investigations in patients with previous documented/suspected reaction: The ordering physicians are encouraged to discuss the indication for contrast administration with the radiologist for alternative imaging. In decreasing order of desirability: 1. Methylprednisolone sodium succinate (Solu-Medrol ) 40 mg or hydrocortisone sodium succinate (Solu-Cortef ) 200 mg intravenously every 4 hours (q4h) until contrast study required plus diphenhydramine 50 mg IV 1 hour prior to contrast injection. 2. Dexamethasone sodium phosphate (Decadron ) 7.5 mg or betamethasone 6 mg intramuscularly q4h until contrast study must be done in patent with known allergy to methylprednisolone, aspirin, or non-steroidal antiinflammatory drugs, especially if asthmatic. Also diphenhydramine 50 mg IV 1 hour prior to contrast injection. 3. Omit steroids entirely and give diphenhydramine 50 mg IV. Note: IV steroids have been shown to be less effective when administered less than 4 to 6 hours prior to contrast injection. c. Pediatric pre-medication Prednisone mg/kg PO (up to 50 mg) 13 hours, 7 hours, and 1 hour prior to contrast administration AND Diphenhydramine (Benadryl ) 1.25 mg/kg PO (up to 50 mg) 1 hour prior to contrast administration Page 5 of 19

6 d. Use of these pre-medication regimens may result in impairments that affect the patient s ability to drive. Appropriate precautions are advised i.e., designated driver. e. The non-emergent patients with contrast allergy, severe enough to require premedication may not be scanned after hours. The pre medication may be scheduled in such a way that the patient is scanned the first thing next morning, when we have full manpower to handle any breakthrough reactions. f. If clinical situation warrants emergent scanning after hours in a patient who has received either the premedication for prior contrast allergy: The afterhours scanning of the premedicated patient should be approved by the faculty member during the day. The on-call 5-6 PM, long or short call resident (as applicable) is to be informed by the day team about the scanning of premedicated patient. The technologist will page the on-call resident before administering the contrast. The on-call resident may request a LIP from the medical team to be present with the patient at the time of scanning g. On call and on weekends, any case with contrast allergy should go through the on-call resident to determine if the study needs to be done after hours or to suggest alternative method of scanning vs. premedication. h. For CT studies, imaging of premedicated patients after hours may be done on the ETC scanner if possible. 2. Emergent contrast administration in life-threatening situations In cases of life-threatening emergency requiring administration of IV contrast and where the ordering provider cannot wait for the premedication by the acute/semi-acute protocol requiring administration of steroids 4 hours and 1 hour prior to the procedure and the alternative test is not acceptable: a. The ordering physician must add a note in the medical record of the patient prior to the contrast administration which clearly states the following: Indication of the urgent study. Reason why the alternative exam (if offered by the radiologist) is not acceptable. Ensure that sufficient staff capable of handling the severe contrast reaction; including intubation and administration of life support drugs will be available during and after the procedure. b. You may consider giving hydrocortisone 200 mg IV AND diphenhydramine (Benadryl ) 50 mg IV stat prior to contrast administration and 4 hours later to cover delayed reaction, although according to the ACR manual IV steroids have not been shown to be effective when administered less than 4 to 6 hours prior to contrast injection. Page 6 of 19

7 B. INTRAVENOUS GADOLINIUM BASED CONTRAST AGENTS Patients with impaired renal function who receive IV gadolinium-based contrast agents (GBCA) for MRI or MRA exams are at risk for developing a serious side effect called nephrogenic systemic fibrosis (NSF), previously known as nephrogenic fibrosing dermopathy (NFD). Patients at risk for NSF are those with severe or end-stage chronic kidney disease (CKD 4 or 5) or acute kidney injury (AKI). However, the greatest risk occurs in patients with end-stage kidney disease on renal dialysis. Patients with AKI, the group at next greatest risk, account for 12-20% of NSF cases. The exact NSF risk is unknown, but is probably in the range of 1-7% after one or more exposures to IV GBCA. The FDA has issued a black box warning for GBCA, which requires patients to be screened for acute kidney injury and other conditions that may reduce renal function. In addition, IV GBCA can cause allergic reactions, which are biologically similar to those observed with IV iodinated contrast agents formulated for use in CT, but are less frequent. 1. Screening for impaired renal function a. Patients with the conditions below are at risk for impaired renal function and must have a serum creatinine with estimated GFR (egfr) checked prior to administration of IV GBCA: Age > 60 years old Diabetes Mellitus (insulin-dependent, oral hypoglycemic or diet-controlled) History of renal disease (includes renal insufficiency or failure, solitary kidney, renal transplant, renal tumor) Other conditions as deemed appropriate by the responsible radiologist b. For outpatients with risk factors described above in subheading a, an acceptable time window for prior egfr laboratory testing, if available, is outlined in the table below (adapted from the ACR Manual on Contrast Media, Version 8, 2012): c. For all inpatients, egfr level should be obtained within two days prior to GBCA administration. Page 7 of 19

8 d. Identify risk factors for AKI, including recent surgery, severe infection, severe trauma and nephrotoxic drugs egfr is not a reliable indicator of AKI. e. Patients currently on dialysis (hemodialysis, peritoneal dialysis or continuous dialysis) do not need to have their egfr checked. Dialysis patients represent 80% of all reported NSF cases. The ordering provider should indicate if the patient is on continuous dialysis (CVVHD, etc.) as these patients are at high risk for NSF, but may appear to have an egfr >30 ml/min/1.73m Administration of Gadolinium contrast agents for patients with impaired renal function a. Whenever possible, MR with IV GBCA should be avoided in patients on dialysis or with AKI or CKD stage 4 or 5 (egfr <30 ml/min/1.73m 2 ). However, if imaging with GBCA is essential and no suitable alternative is available, the following procedure must be followed: The responsible radiologist and ordering physician must discuss the clinical appropriateness, alternatives and urgency of the proposed MR exam and agree that the benefits outweigh the risks. The patient will be given copy of Information Sheet for Patients Scheduled for Contrast-Enhanced MRI. (Appendix A). The responsible radiologist will explain the risks and benefits of the proposed MRI exam and the patient will have an opportunity to discuss any concerns. If the patient agrees to proceed with the MRI exam, the radiologist will obtain verbal informed consent. The ordering physician must add a note in the medical record of the patient prior to the contrast administration which clearly states the benefit outweighs the risk. The radiology report must document the above discussions and verbal informed consent. The MR exam should be performed with the smallest possible dose of GBCA necessary to obtain a diagnostic study. The only permissible IV GBCA is Gadavist (gadobutrol)). The contrast agent can be administered only once during an imaging session. Omniscan (gadodiamide), Magnevist (gadopentetate dimeglumine) and OptiMARK (gadoversetamide) are contraindicated in patients on dialysis or with AKI or CKD stage 4 or 5 (per FDA warning dated 9/10/2010). b. Try to limit the cumulative dose of GBCA over several MR exams because this may increase NSF risk. c. For current hemodialysis patients, dialysis should be performed as soon as possible, but no later than 24 hours, after an MRI exam with IV gadolinium-based contrast agent. To date, hemodialysis has NOT been proven to decrease NSF risk. Page 8 of 19

9 3. Administration of Gadolinium contrast agents for various MRI exams a. Most contrast-enhanced MRI exams will be performed with single dose IV Gadavist (gadobutrol) 0.1 mmol/kg (0.1 ml/kg) body weight. If a patient has had previous contrast reactions or nausea/vomiting to Gadavist (gadobutrol), use Magnevist (gadopentetate dimeglumine) at 0.1 mmol/kg (0.2 ml/kg) if no risk of NSF. b. Some abdominal MRI exams of the liver and biliary tree may be performed with IV Eovist (gadoxetate disodium) (0.2 ml/kg). c. MR Enterography exams will be performed IV Gadavist (gadobutrol) at 0.15 ml/kg. If patient has a history of contrast reactions or nausea/vomiting to Gadavist (gadobutrol), use Magnevist (gadopentetate dimeglumine) at 0.3 ml/kg. d. Contrast-enhanced MRA exams will be performed with IV Gadavist (gadobutrol) as follows: Single station MRA 10 ml Gadavist (gadobutrol). Two or three station MRA 15 ml Gadavist (gadobutrol) diluted with 25 ml saline to 40 ml total volume. e. Contrast-enhanced cardiac MRI exams for myocardial viability will be performed with IV Gadavist (gadobutrol) 0.2 ml/kg. f. Pediatric Patients: Contrast-enhanced MRI exams will be performed with single dose IV Gadavist (gadobutrol): 0.1 ml/kg body weight in patients over 50 kg (110 lbs). Contrast-enhanced MRI exams will be performed with single dose IV Magnevist (gadopentetate): 0.2 ml/kg body weight in patients under 50 kg (110 lbs). MRA Neck, Brain, and MRV Brain will be performed with single dose IV Gadavist (gadobutrol): 0.1 ml/kg body weight in all patients diluted with saline to equal the dose of Gadavist (gadobutrol) for patients less than 50 kg (110 lbs). All other MRA s below neck will be performed with double dose IV Gadavist (gadobutrol) for patients less than 50 kg (110 lbs): 0.2 ml/kg body weight in all patients dilute with saline < dose of Gadavist (gadobutrol) so the total volume injected is no more than 10 ml. Contrast-enhanced MRA exams for patients over 50 kg (110 lbs) will be performed with IV Gadavist (gadobutrol) as follows: 1. Single station MRA - 10 ml Gadavist (gadobutrol) 2. Two or three station MRA 15 ml Gadavist (gadobutrol) diluted to 40 ml with saline. MR Enterography exams will be performed IV Gadavist (gadobutrol) at 0.15 ml/kg or Magnevist (gadopentetate) 0.3 ml/kg if patient has had previous contrast reactions to Gadavist (gadobutrol) or nausea/vomiting. Page 9 of 19

10 4. Prevention of Contrast Reactions Allergic-type reactions to GBCA are rare and severe or anaphylactoid reactions are extremely rare. In patients who have previously reacted to a GBCA or experienced nausea/vomiting, there are no definitive studies to support the efficacy of premedication in reducing the incidence of subsequent reactions. Nonetheless, in the absence of such data, it is reasonable to follow a common sense approach. a. Use a different gadolinium-based agent. b. At the discretion of the radiologist, premedicate the patient with steroids and antihistamine in accordance with the policy for iodinated contrast may be considered: Premedication for Iodinated IV contrast (page 5) 5. Emergency MR exams (with contrast) This section pertains to the following circumstances: a. Request is for an emergency MR study or studies b. Patient would ordinarily require egfr screening for renal insufficiency c. No current serum egfr is available d. The referring physician believes that a delay in performing the MR study due to obtaining a serum egfr would compromise patient care. e. At the discretion of the responsible radiologist, such patients may undergo an MR exam with Gadavist (gadobutrol) without a current egfr. f. The ordering physician must add a note in the medical record of the patient prior to the contrast administration which clearly states the benefit outweighs the risk. g. The radiology report must document the above discussions and verbal informed consent. Page 10 of 19

11 C. INTRA-ARTERIAL IODINATED CONTRAST ADMINISTRATION 1. For intra-arterial iodinated contrast injections, the same general rules apply as for intravenous iodinated contrast injections. 2. For run-off angiograms for peripheral vascular disease, use of Visipaque (iodixanol) may be preferred by some (compared to Isovue [iopamidol]) in effort to decrease the somatic effects typical of iodinated contrast. 3. In patients with severe contrast allergy, gadolinium may be used per protocol in section B. D. NON-INTRAVENOUS CONTRAST AGENTS 1. Oral contrast agents such as barium and diatrizoate sodium-meglumine (MD-Gastroview, Gastrografin ) are medications and preparation and administration must be under the supervision of a licensed independent practitioner. 2. All procedures requiring the administration of oral contrast agents must have a written Radiology procedure protocol that is developed by a radiologist. 3. For swallow studies, where there is an inherent risk for aspiration, non-ionic, iso-osmolar contrast Visipaque (iodixanol) is preferred. 4. Protocols for administration and preparation of oral contrast must be reviewed by the Drug Information Center and approved by the P&T Subcommittee and by the appropriate radiologist or radiologists when the standards of care and application change or when the characteristics of the oral contrast agent change. 5. Orders for contrast administration are reviewed by a radiologist or licensed independent practitioner to determine appropriateness. The currently used oral contrast preparations for CT, MRI, and fluoro procedures have minimal adverse effects. A pharmacist is available on the 4JP satellite to answer any questions the radiologist or licensed independent practitioner may have. 6. Oral contrast agents that are sent to the in-patient floor by radiology technicians must include the following information: a. Drug name, strength, and amount (if not apparent from the container) b. Time and date the contrast was prepared, an expiration date, and initials of the person who prepared the container. c. Name of patient, medical record number, date of birth, and location of the patient. d. Directions for use and any applicable cautionary statements. Instructions on administration times in relation to Radiology procedure. 7. Quality control procedures are implemented to prevent retrieval errors. a. Oral contrast is stored segregated from other medications and clearly labeled. 8. A percentage of records for cases that did not have a pharmacy review prior to dispensing are sampled quarterly per protocol to determine if the system functions successfully as designed. Page 11 of 19

12 E. ULTRASOUND CONTRAST AGENTS Currently, there is no FDA approved ultrasound contrast agent. However, at UIHC, clinical studies are performed under IRB and FDA guidance, for which patients will receive separate informed consent and detailed information. Should a clinician wish to discuss such studies, he should be directed to the responsible radiologist. F. PEDIATRIC IV CONTRAST ADMINISTRATION 1. For iodinated contrast media agents, the same principles apply in adults as in children. The dose of contrast is delivered based on weight of the patient (2 ml/kg). 2. For gadolinium agents, a dose is similarly prescribed based on body weight (see point 3 in gadolinium administration paragraph). Pediatric patients (page 9) References for pediatric contrast media use: a. Manual/Contrast%20Media%20in%20Children.pdf b. c. d. e. Page 12 of 19

13 G. TREATMENT OF CONTRAST MEDIA REACTION In all cases, treatment should begin with: IV access and monitor frequent vitals Maintain the ABCs (airway, breathing, circulation) Notify the radiologist Call Code Blue, Rapid Response or 911 (at IRL) for severe reactions Complete contrast reaction note and document allergy in EMR Follow up call to patient the next day (done by nursing staff and documented in EMR) Table 1: Suggested Treatments for Adults w/ Adverse Effects to Contrast Agents Hives Mild None Observe until resolving (Scattered & transient) Moderate (numerous & bothersome to the patient) Diphenhydramine (Benadryl ) OR mg oral (causes drowsiness; patient will need a designated driver) Fexofenadine 180 mg po (for patients without a driver) Severe (profound) Secure IV access 50 mg IV Diphenhydramine (Benadryl ) Diffuse erythema Mild Severe Laryngeal edema Bronchospasm Secure IV access, IV fluids Consider: diphenhydramine Consider: hydrocortisone Epinephrine CALL CODE Secure IV access, O 2 by mask 10 l/min O 2 Epinephrine CALL CODE Hydrocortisone 0.9% NaCl or Lactated Ringer s 1-2 liters IV 50 mg oral or IV 200 mg IV 0.3 mg /0.3 ml IM (1:1,000), if inadequate response; 0.1 mg/1 ml (1:10,000) slow IV; repeat as needed up to 1 mg/10 ml total dose 0.1 mg/1 ml (1:10,000) slow IV; repeat as needed up to 1 mg/10 ml total dose 200 mg IV, repeat if necessary Mild Albuterol inhaler 2 puffs, repeat as necessary Secure IV access, O 2 by mask 10 l/min O 2 Moderate Epinephrine IM* 0.3 mg/0.3 ml (1:1,000) IM; may repeat once Severe Epinephrine IV 0.1 mg/1 ml (1:10,000) slow IV; repeat as needed up to 1 mg/10 ml total dose CALL CODE Page 13 of 19

14 Table 1 (cont): Suggested Treatments for Adults w/ Adverse Effects to Contrast Agents Pulmonary Edema Secure IV access O 2 by mask 10 l/min O 2 Elevate head of bed Furosemide Morphine CALL CODE Hypotension with Bradycardia mg IV, slowly ( 10 mg/minute) 1-3 mg IV, repeat every 5-10 min as needed Mild Elevate legs Secure IV access, IV fluids 0.9% NaCl or Lactated Ringer s 1-2 liters O 2 by mask 10 l/min O 2 Severe Atropine 0.6 mg 1 mg IV, slow; up to 2-3 mg total dose (0.04 mg/kg) Hypotension with Tachycardia Mild Severe Elevate legs Secure IV access IV fluids O 2 by mask 10 l/min O 2 Epinephrine 0.9% NaCl or Lactated Ringer s 1-2 liters 0.1 mg/1 ml (1:10,000) slow IV; repeat as needed up to 1 mg (10 ml total dose) CALL RAPID RESPONSE Hypertension Crisis (diastolic BP > 120 mmhg) Secure IV access O 2 by mask 10 l/min O 2 Labetalol (first choice) 20mg IV over 2 minutes, may repeat q 10 minutes 40 mg IV slowly (over at least 4 minutes) Furosemide (if labetalol is not available) Nitroglycerin 0.4 mg sublingual; repeat after 5-10 min x 3 CALL RAPID RESPONSE Hypoglycemia (blood sugar below 50-60) If patient is able to swallow safely If patient is unable to swallow safely Secure IV access O 2 by mask 6-10 L/min O 2 Administer oral glucose 15 grams of glucose tablet/gel or ½ cup (4 oz) of fruit juice If IV access present, administer Dextrose 50% IV If IV access not present, administer Glucagon D50W IV 1 ampule (25 grams) IV push over 2 minutes (rate 100 ml/hr) 1 mg (1 mg/ml) IM/SQ Following Glucagon treatment provide a snack * In hypotensive patients, the preferred route of epinephrine delivery is IV as the extremities may not be perfused sufficiently to allow adequate absorption of IM administration Page 14 of 19

15 H. TREATMENT AND PREVENTION OF CONTRAST EXTRAVASATION Methods to Decrease the Risk of Extravasation during Injection of Contrast Media 1. Most CT and MRI protocols use power injectors. In angiography/intervention there is a mix of power and hand injections. There is preference for 20-gauge or larger catheters/cannulas with flow rates of 3 ml/second or higher. 2. Extravasations have incidence of 1/1000 to 1/106 patients when a power injector is used. 3. Patients should be instructed about potential extravasation and how to alert the technician. All injections should be monitored during the first seconds of injection to ensure no extravasation occurs early. Communication with the patient should continue via intercom during injection. 4. Use of standard central venous catheters should be discouraged, but Power PICC lines (purple) and Power Ports may be used for contrast injection should the situation demand it. 5. Extravasation of MRI contrast media is rare and generally constitutes relatively small quantities, thus limiting the risk for compartment syndrome. 6. Extravasation of any contrast volume should be treated in accordance with the following paragraphs. 7. Risk factors that have been identified for contrast extravasation include: a. Inadequate communication (elderly, altered consciousness) b. Severely ill/debilitated patients c. Patients with abnormal circulation to limb to be injected (atherosclerosis, Raynaud s disease, venous thrombosis/insufficiency, prior radiation therapy, previous [axillary] surgery) d. More peripheral injection sites (hand, wrist, foot, ankle) e. Injection through line that has been present >24 hrs Treatment of Extravasation of IV Contrast Media 1. Observation is required if extravasation <100 ml low osmolar contrast media: a. Notify radiologist. b. Elevate affected limb above the heart. Check the pulses and sensations. c. No clear evidence favoring the use of warm or cold packs ( ACR manual 2010). Suggested applying cold pack for immediate relief of pain and burning x 30 minutes followed by warm pack x hours to facilitate absorption of the contrast. d. If >5 ml extravasated: observation for 2-4 hours. e. The radiologist may at his/her discretion discharge a patient less than 2-4 hours with gadolinium agent extravasation. The guidelines for IV contrast media extravasation may be referred to as needed. f. Watch for increasing pain, swelling, blisters, numbness or tingling. g. Disposition to be determined by the radiologist or the LIP. h. Record the event and the treatment in the patients chart. 2. Surgical (plastic surgery) consultation is required in the following situations: a. Extravasation >100 ml low-osmolar contrast media. b. Increased swelling or pain after 2-4 hours. c. Altered tissue perfusion. d. Change in sensation or temperature. e. Development of skin ulceration or blistering. Page 15 of 19

16 I. PREGNANCY AND BREAST FEEDING Pregnancy 1. During pregnancy, it is safe practice to limit ionizing radiation as well as MRI investigations as much as possible. Nevertheless, the risk of missing a diagnosis or mismanagement in the absence of a significant diagnosis will take precedent over any risks to the mother and fetus. 2. The administration of iodinated contrast and oral contrast agents has no known risks during any trimester. 3. For gadolinium-based contrast agents there is insufficient data at present, and therefore these agents should NOT be routinely administered during pregnancy. a. The decision to use intravenous contrast must be made on a case-by case basis by the attending radiologist, who will confer with the referring physician to assess the risk benefit tradeoffs for that patient. The medical necessity to use contrast during pregnancy must be documented in the patient s medical record by the attending physician who requested the study must be in the patient s medical record before procedure can be performed. b. If it is determined that contrast is needed, the patient or legal guardian must sign a procedural consent form (G-2d 2 ) after they are made aware of the potential risks and benefits of the proposed MR procedure and the availability of alternative diagnostic tests (if any). Breast Feeding The literature on the excretion into breast milk of iodinated and gadolinium-based contrast media and the gastrointestinal absorption of these agents from breast milk is very limited; however, several studies have shown that 1) less than 1% of the administered maternal dose of contrast medium is excreted into breast milk; and 2) less than 1% of the contrast medium in breast milk ingested by an infant is absorbed from the gastrointestinal tract. Therefore, the expected dose of contrast medium absorbed by an infant from ingested breast milk is extremely low. 1. Iodinated contrast agents are excreted rapidly through the kidneys, and less than 1% is excreted into breast milk during the first 24 hours. Therefore, it is considered safe for the mother to continue breast feeding after receiving iodinated contrast. 2. Gadolinium contrast is excreted rapidly through the kidneys, and less than 0.04% is excreted into breast milk during the first 24 hours. Therefore, it is considered safe to continue breast feeding after receiving Gadolinium contrast. Patients will be given the Breast Feeding Information Form (Appendix B) prior to their MRI procedure. 3. If the patient has any question or concerns they can speak to a radiologist. 4. If the patient still has concerns they can pump and throw their milk away for the next 24 hours after their injection of gadolinium. Page 16 of 19

17 J. APPENDIX A: INFORMATION SHEET FOR CONTRAST ENHANCED MRI Information Sheet for Patients Scheduled for Contrast-Enhanced MRI Your doctor or health care provider has ordered a Magnetic Resonance Imaging (MRI) test with intravenous contrast to help evaluate your medical condition. The MRI contrast contains a metal called gadolinium, which increases the diagnostic capability of MRI. Unlike the x-ray dyes used for CT scans, MRI contrast agents do not contain iodine and have enjoyed a generally excellent safety profile after 20 years and more than 200 million doses worldwide. However, recent reports in the medical literature have identified an association between gadolinium contrast and a rare, debilitating disease called Nephrogenic Systemic Fibrosis (NSF). First described in 1997, NSF can affect the skin, muscles, and internal organs. The skin can become thick, hard, tight, dark and itchy. NSF occurs exclusively in patients with severely impaired kidney function, particularly those on kidney dialysis. The disease is rarely fatal, but there is no consistently successful treatment. The cause of NSF and the exact role of gadolinium contrast are unknown. In patients with severely impaired kidney function, the risk of developing NSF from gadolinium contrast is not precisely known, but is probably small (3-7%). After carefully considering your medical condition, your doctor and the supervising radiologist believe that an MRI with gadolinium contrast is medically indicated and is more likely to provide important diagnostic information than alternative imaging tests. Also, your doctors believe that the potential benefits of MRI with gadolinium contrast outweigh the risks. To minimize your chances of developing NSF, your radiologist will perform the MRI with one of three gadolinium contrast agents thought to pose a smaller risk of NSF. We will use the lowest possible contrast dose consistent with making a diagnostic study. If you are currently on hemodialysis, you will be dialyzed promptly after your MRI to help remove the gadolinium contrast from your body. The US Food and Drug administration (FDA) cautions that all gadolinium contrast agents may pose a risk of NSF. Your radiologist, who is a physician with expertise in medical imaging, will be glad to answer any questions or concerns that you may have about your MRI or the intravenous contrast agent. Page 17 of 19

18 K. APPENDIX B: BREAST FEEDING INFORMATION FORM University of Iowa Hospitals and Clinic Department of Radiology MRI 0440 JCP 200 Hawkins Drive Iowa City, Iowa / / Fax Your doctor as ordered an MRI exam that requires us to give you a gadolinium contrast agent for this exam. Gadolinium is a type of contrast agent that will be injected in a vein in your arm and will give the radiologist additional information when reading your images. After injection of the gadolinium contrast agent a tiny amount will be excreted into your breast milk. A review of the literature shows there is no evidence to suggest that the oral intake of your breast milk by your baby that contains the tiny amount of gadolinium would cause toxic effects to your baby. It is believed that the available data suggest that it is safe for you to have your baby continue breast feeding after receiving an injection of gadolinium contrast agent. If you remain concerned about any potential ill effects, you can speak to a radiologist so you can make an informed decision as to whether to continue breast-feeding or temporarily stop breastfeeding after receiving a gadolinium contrast agent. If you so desire, you can stop breast-feeding for 24 hours and pump both breasts if needed and throw the pumped breast milk away. After 24 hours you can resume normal breast feeding. If you have any questions and would like to speak to a radiologist please ask the receptionist. Page 18 of 19

19 Reviewed by Department of Pharmaceutical Care (March 2012, March 2013) Reviewed by Department of Anesthesiology (April 2005) Approved by the Pharmacy and Therapeutics Subcommittee (March 2012, March 2013) Approved by Radiology Quality Assurance Committee (March 2012, January 2013) Page 19 of 19