Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Prevention of Contrast Media Associated Adverse Drug Events - Adult/Pediatric - Inpatient/Ambulatory External Clinical Practice Guideline Endorsement Note: Active Table of Contents – Click each header below to jump to the section of interest Table of Contents INTRODUCTION ........................................................................................................................................... 4 SCOPE ........................................................................................................................................................... 4 Intended Users ............................................................................................................................ 4 Objective ...................................................................................................................................... 4 Target Population ........................................................................................................................ 4 Clinical Questions Considered .................................................................................................... 4 DEFINITIONS ................................................................................................................................................ 5 RECOMMENDATIONS ................................................................................................................................. 5 Prevention and management of contrast-induced acute kidney injury and adverse reactions . 5 Contrast media use in patients receiving interleukin-2 therapy ................................................. 5 Timing of dialysis after contrast media administration in renal dialysis patients........................ 5 Treatment of contrast reaction-associated hypertensive crisis in adults ................................... 5 DISCLAIMER ................................................................................................................................................. 5 METHODOLOGY .......................................................................................................................................... 6 Development Process ................................................................................................................. 6 Methods Used to Collect/Select the Evidence............................................................................ 6 Literature Sources ....................................................................................................................... 6 Search Terms Included ............................................................................................................... 6 Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations: ...... 7 Rating Scheme for the Strength of the Evidence/Recommendations ........................................ 7 GRADE Ranking of Evidence ..................................................................................................... 7 GRADE Ratings for Recommendations for or Against Practice ................................................ 7 COLLATERAL TOOLS & RESOURCES...................................................................................................... 8 Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 UW Health Hospitals & Clinics .................................................................................................... 8 REFERENCES............................................................................................................................................... 8 Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Content Experts: Name: Robert Bour, MD- Radiology Phone Number: (608) 263-9028 Email Address: rbour@wisc.edu Name: Lori Mankowski-Gettle, MD, MBA Phone Number: (608) 263-8231 Email Address: lmankowskigettle@uwhealth.org Contact for Changes: Name: Philip Trapskin, PharmD, BCPS – Pharmacy, Drug Policy Program Phone Number: (608) 263-1328 Email Address: ptrapskin@uwhealth.org Guideline Authors: Kaylyn Dougherty, PharmD – Pharmacy Daniel Kapp, PharmD – Pharmacy Molly Naef, MSN, RN – CCKM Workgroup Members: Jessica Dern – Professional Service Kara Gill, MD – Radiology Terry Gion, DNP, RN – Radiology Gina Greenwood – Radiology Carol Hassemer – Medical Imaging Jeffrey Kanne, MD – Radiology Kristi Klein – Radiology Kandace Nowakowski – Radiology Meghan Lubner, MD – Radiology Julie Pawola – Pharmacy Sara Pivovar – Pharmacy Tyler Prout, MD – Radiology Kari Pulfer – Medical Imaging Humberto Rosas, MD – Radiology Monaco Rosemary – Nursing Heather Schrant – Pharmacy Brian Sparland – Medical Imaging Chelsea Stietz – Clinical Analyst Michelle Thoma – Pharmacy Michael Tuite, MD – Radiology Peter Wasmund – Radiology Reviewers: Meghan Lubner, MD – Radiology Committee Approval(s): Pharmacy & Therapeutics Committee (03/19/2020-electronic vote) Plan for Review: All Clinical Practice Guidelines are reviewed at a minimum of every five years. Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Introduction Contrast media are an essential component of modern medical imaging. While the safety of contrast media use has improved over time, there remains a non-negligible degree of risk that is dependent on situation-specific factors; therefore, for each patient, practitioners must weigh the risk of contrast-associated adverse events against the potential benefit of enhanced imaging from the use of contrast media. To ensure the optimal use of contrast media, UW Health endorses recommendations from the American College of Radiology (ACR) (ACR Manual on Contrast Media; [2020 Version 10.3])1 and the National Kidney Foundation (Consensus Statements from the American College of Radiology and the National Kidney Foundation [Radiology 2020; 00:1-9]).2 Additional UW Health-specific recommendations for the management of patients receiving interleukin-2 therapy, timing of hemodialysis, and management of hypertensive crisis are provided. Scope Intended Users Physicians, Advanced Practice Providers, Registered Nurses, Radiologic Technologists, Pharmacists, Radiology support staff Objective To provide standardized, evidence-based, system-wide guidelines for the administration and care of patients receiving contrast media. Target Population Pediatric and adult patients requiring contrast media and presenting to Radiology or Medical Imaging departments. Clinical Questions Considered • Safe administration of contrast media • Prevention of contrast-induced acute kidney injury • Prevention and management of contrast media-associated reactions • Prevention and management of contrast media extravasation Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Definitions Contrast-associated acute kidney injury (CA-AKI): Any AKI occurring within 48 hours after the administration of contrast media.2 The term postcontrast acute kidney injury (PCAKI) is synonymous with CA-AKI and appears in radiology guidelines. Both terms imply correlative diagnosis, but neither term implies a causal relationship between contrast medium administration and an AKI event. Contrast-induced acute kidney injury (CI-AKI): CI-AKI is the subset of CA-AKI that can be causally linked to contrast media administration.2 CI-AKI implies a causal relationship between intravenous contrast media and the development of AKI (ie, contrast induced). Recommendations Prevention and management of contrast-induced acute kidney injury and adverse reactions UW Health endorses recommendations from the American College of Radiology (ACR Manual on Contrast Media; [2020 Version 10.3])1a and the National Kidney Foundation (Consensus Statements from the American College of Radiology and the National Kidney Foundation [Radiology 2020; 00:1-9]).2b Contrast media use in patients receiving interleukin-2 therapy Patients who are currently receiving or were recently treated with IL-2 therapy may have an increased risk of delayed reactions.3–5 Providers should provide education on the potential risk of delayed reactions and may consider observation of a patient who is currently receiving or was recently treated (eg, within 6 months) with IL-2 therapy for 30 minutes after administration of contrast media (UW Health GRADE Moderate, conditional recommendation). Timing of dialysis after contrast media administration in renal dialysis patients For most patients with CKD, the initiation or rescheduling of acute dialysis or continuous renal replacement therapy is not required due solely to the administration of contrast media.2 However, for patients established on dialysis, providers may consider adjustment of the dialysis schedule so that dialysis occurs within 24-48 hours after contrast administration with the goal to reduce intravascular load (UW Health GRADE Strong, conditional recommendation). This recommendation is based on expert consensus and considers the theoretical risk of pulmonary edema and anasarca with potential osmotic overload. Treatment of contrast reaction-associated hypertensive crisis in adults Clonidine may be considered as an oral treatment option for patients with contrast reaction- associate hypertensive crisis who have a contraindication to nitrates (eg, nitroglycerin) or other standard anti-hypertensive therapies (UW Health GRADE Moderate, conditional recommendation).6,7 Use of clonidine should be avoided in patients with heart failure, heart block, or hypertensive encephalopathy due to risks of sedation and neurological assessment interference. Disclaimer Clinical practice guidelines assist clinicians by providing a framework for the evaluation and treatment of patients. This guideline outlines the preferred approach for most patients. It is not intended to replace a clinician’s judgment or to establish a protocol for all patients. It is aAvailable at: https://www.acr.org/Clinical-Resources/Contrast-Manual bAvailable at: https://pubs.rsna.org/doi/10.1148/radiol.2019192094 Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 understood that some patients will not fit the clinical condition contemplated by a guideline and that a guideline will rarely establish the only appropriate approach to a problem. Methodology Development Process Each guideline is reviewed and updated a minimum of every 3 years. All guidelines are developed using the guiding principles, standard processes, and styling outlined in the UW Health Clinical Practice Guideline Resource Guide. This includes expectations for workgroup composition and recruitment strategies, disclosure and management of conflict of interest for participating workgroup members, literature review techniques, evidence grading resources, required approval bodies, and suggestions for communication and implementation. The workgroup members agreed to adopt recommendations developed by external organizations and/or created recommendations internally via a consensus process using discussion of the literature and expert experience/opinion. If issues or controversies arose where consensus could not be reached, the topic was escalated appropriately per the guiding principles outlined in the UW Health Clinical Practice Guideline Resource Guide. Methods Used to Collect/Select the Evidence The following sources were used by the guideline authors and workgroup members to conduct electronic database searches for the collection of additional evidence. Searches were extended to reviews and studies conducted in humans and published in English between 1980 and 2020. Reference lists of relevant studies were also reviewed. Literature Sources • Electronic database search (e.g., MEDLINE) • Databases of systematic reviews (e.g., Cochrane Library) • Agency for Healthcare Research and Quality Reports Search Terms Included • Interleukin • Contrast reaction • Adverse reaction • Recall reaction • Delayed reaction • Dialysis • Hemodialysis • Hemofiltration • Contrast • Iodinated contrast • Gadolinium Current resources from University of Wisconsin Department of Radiology and UW Health Hospitals & Clinics were also reviewed and reconciled with the ACR Manual on Contrast Media See Collateral Tools and & Resources. Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations: Recommendations developed by external organizations maintained the evidence grade assigned within the original source document and were adopted for use at UW Health. Internally developed recommendations, or those adopted from external sources without an assigned evidence grade, were evaluated by the guideline workgroup using an algorithm adapted from the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. See Figure 1. Rating Scheme for the Strength of the Evidence/Recommendations Figure 1. GRADE Methodology adapted by UW Health GRADE Ranking of Evidence High We are confident that the effect in the study reflects the actual effect. Moderate We are quite confident that the effect in the study is close to the true effect, but it is also possible it is substantially different. Low The true effect may differ significantly from the estimate. Very Low The true effect is likely to be substantially different from the estimated effect. GRADE Ratings for Recommendations for or Against Practice Strong The net benefit of the treatment is clear, patient values and circumstances are unlikely to affect the decision. Conditional Recommendation may be conditional upon patient values and preferences, the resources available, or the setting in which the intervention will be implemented. Effective 03-19-2020. Contact CCKM@uwhealth.org for previous versions. Copyright © 2020 University of Wisconsin Hospitals and Clinics Authority. All Rights Reserved. Printed with Permission Contact: CCKM@uwhealth.org Last Revised: 05/20/2020 Collateral Tools & Resources The following collateral tools and resources support staff execution and performance of the evidence-based guideline recommendations in everyday clinical practice. UW Health Hospitals & Clinics Order Sets & Smart Sets (pending revision) • IP- Contrast Induced Nephropathy Prophylaxis- Heart Failure • IP- Contrast Induced Nephropathy Prophylaxis- Adult Contrast Treatment Prophylaxis Order Sets & Smart Sets • IP- Intravenous Iodinated/Gadolinium Contrast Prophylaxis- Adult – Supplemental • OP- Intravenous Iodinated/Gadolinium Contrast Prophylaxis- Adult – Supplemental • ED/IP- Radiology Rapid Contrast Reaction Prophylaxis- Adult - Supplemental Protocols • OP - Delegation Protocol for Surgical Oncology – Adult Contrast Reaction Treatment Order Sets & Smart Sets • IP/OP – Contrast Reaction Treatment – Adult • IP/OP – Contrast Reaction Treatment – Pediatric References 1. ACR Committee on Drugs and Contrast Media. ACR Manual On Contrast Media 2020 ACR Committee on Drugs and Contrast Media. v10.3. American College of Radiology; 2020. https://www.acr.org/-/media/ACR/Files/Clinical-Resources/Contrast_Media.pdf. Accessed March 2, 2020. 2. Davenport MS, Perazella MA, Yee J, et al. Use of Intravenous Iodinated Contrast Media in Patients with Kidney Disease: Consensus Statements from the American College of Radiology and the National Kidney Foundation. Radiology. 2020;294(3):660-668. doi:10.1148/radiol.2019192094 3. Boehm I. Is interleukin-2 therapy still a risk factor for adverse reactions in concert with iodinated contrast medium injection? Acta radiol. 2009;50(7):752-753. doi:10.1080/02841850903061452 4. Choyke PL, Miller DL, Lotze MT, Whiteis JM, Ebbitt B, Rosenberg SA. Delayed reactions to contrast media after interleukin-2 immunotherapy. Radiology. 1992;183(1):111-114. doi:10.1148/radiology.183.1.1549655 5. Webb JAW, Stacul F, Thomsen HS, et al. Late adverse reactions to intravascular iodinated contrast media. Eur Radiol. 2003;13(1):181-184. doi:10.1007/s00330-002- 1650-5 6. Atkin SH, Jaker MA, Beaty P, Quadrel MA, Cuffie C, Soto-Greene ML. Oral labetalol versus oral clonidine in the emergency treatment of severe hypertension. Am J Med Sci. 1992;303(1):9-15. doi:10.1097/00000441-199201000-00004 7. Wright BM, Adams M, Karwa R, Varela G, Nesmith J, Rutecki GW. Treatment choices for severe hypertension. Consultant. 2011;51(7):449-456. https://www.consultant360.com/content/treatment-choices-severe-hypertension. Accessed March 4, 2020. Introduction Scope Intended Users Objective Target Population Clinical Questions Considered Definitions Recommendations Prevention and management of contrast-induced acute kidney injury and adverse reactions Contrast media use in patients receiving interleukin-2 therapy Timing of dialysis after contrast media administration in renal dialysis patients Treatment of contrast reaction-associated hypertensive crisis in adults Disclaimer Methodology Development Process Methods Used to Collect/Select the Evidence Literature Sources Search Terms Included Methods Used to Assess the Quality of the Evidence/Strength of the Recommendations: Rating Scheme for the Strength of the Evidence/Recommendations GRADE Ranking of Evidence GRADE Ratings for Recommendations for or Against Practice Collateral Tools & Resources UW Health Hospitals & Clinics References