Guideline Safe Use of Contrast Media Part 1 This part 1 comprises: 1. Prevention of post-contrast acute kidney injury 2. Use of iodine-containing contrast media in patients with diabetes type 2 who use metformin 3. Use of iodine-containing contrast media in patients undergoing dialysis INITIATED BY Radiological Society of the Netherlands IN ASSOCIATION WITH Netherlands Association of Internal Medicine Dutch Federation for Nephrology Dutch Society of Intensive Care Association of Surgeons of the Netherlands The Netherlands Society of Cardiology Dutch Society for Clinical Chemistry and Laboratory Medicine Netherlands Society of Emergency Physicians Dutch Association of Urology Dutch Society Medical Imaging and Radiotherapy WITH THE ASSISTANCE OF Knowledge Institute of Medical Specialists FINANCED BY Quality Funds of Medical Specialists 1 Guideline Safe Use of Contrast Media – Part 1 Colophon GUIDELINE SAFE USE OF CONTRAST MEDIA – PART 1 ©2017 Radiological Society of the Netherlands Address: Taalstraat 40, 5260 CB Vught 0800 0231 536 / 073 614 1478 [email protected] www.radiologen.nl All rights reserved. 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Address and email: see above. 2 Guideline Safe Use of Contrast Media – Part 1 Index Working group ........................................................................................................... 4 Chapter 1 General Introductions ............................................................................. 5 Chapter 2 Justification of this Guideline ................................................................. 10 Chapter 3 PC-AKI: Definitions, Terminology & Clinical Course.….…………….…………… 19 Chapter 4 Risk Stratification and Risk Stratification Tools ....................................... 26 Chapter 5 Evaluation of estimated glomerular filtration rate (eGFR)....................... 50 Chapter 6 Prevention: Hydration and Complications .............................................. 57 Chapter 7 Other Preventive Measures ................................................................... 76 Chapter 8 Iodine-containing CM use in type-2 DM patients using metformin ........ 120 Chapter 9 Organization of Health Care ................................................................. 126 Chapter 10 Implementation table .......................................................................... 130 Chapter 11 Knowledge Gaps .................................................................................. 139 Chapter 12 Quality Indicators ................................................................................ 142 Nederlandse Samenvatting ..................................................................................... 147 Patiëntensamenvatting ........................................................................................... 147 Flowchart .......................................................................................................... 155 3 Guideline Safe Use of Contrast Media – Part 1 Working group • A.J. van der Molen, radiologist, Leiden University Medical Centre, Leiden (chairman) • R.W.F. Geenen, radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar/Den Helder • T.H. Pels Rijcken, interventional radiologist, Tergooi, Hilversum • H.M. Dekker, radiologist, Radboud University Medical Centre, Nijmegen • A.H. van den Meiracker, internist-vascular medicine, Erasmus Medical Centre, Rotterdam • E.K. Hoogeveen, nephrologist, Jeroen Bosch Hospital, ‘s-Hertogenbosch • H.M. Oudemans - van Straaten, internist-intensive care specialist, Free University Medical Centre, Amsterdam • Y.W.J. Sijpkens, nephrologist, Haaglanden Medical Centre, The Hague • J. Kooiman, research physician, Leiden University Medical Centre, Leiden • C. Cobbaert, clinical chemist, Leiden University Medical Centre (member of advisory board from September 2015) • T. Vainas, vascular surgeon, University Medical Centre Groningen (until September 2015) • O.R.M. Wikkeling, vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten (from September 2015) • P. Danse, interventional cardiologist, Rijnstate Hospital, Arnhem Advisory board • K. Prantl, Coordinator Quality & Research, Dutch Kidney Patient Association • R. Hubbers, patient representative, Dutch Kidney Patient Association • J. Mazel, urologist, Spaarne Gasthuis, Haarlem • J. van den Wijngaard, resident in Clinical Chemistry, Leiden University Medical Center • A.Y. Demir, clinical chemist, Meander Medical Center, Amersfoort, (member of working group until September 2015) • S. Moos, resident in Radiology, HAGA Hospital, The Hague Methodological support • I.M. Mostovaya, advisor, Knowledge Institute of Medical Specialists • S. Persoon, advisor, Knowledge Institute of Medical Specialists (March 2016 – September 2016) • K. Burger, senior advisor, Knowledge Institute of Medical Specialists (until March 2015) • A. van Enst, senior advisor, Knowledge Institute of Medical Specialists (from January 2017) • J. Boschman, advisor, Knowledge Institute of Medical Specialists (from May 2017) • W. Harmsen, advisor, Knowledge Institute of Medical Specialists (from May 2017) 4 Guideline Safe Use of Contrast Media – Part 1 Chapter 1 General Introductions General Introduction New Guideline Set on Safe Use of Contrast Media The Radiological Society of The Netherlands (RSTN - NVvR) deemed a set of new guidelines on the Safe Use of Contrast Media (CM) highly necessary and relevant, due to recent publications on many topics concerning contrast safety. Because of recent scientific developments, the recommendations of the most recent CM guideline (CBO, 2007) were in conflict with what should be considered best clinical practice. In order to update this 2007 CBO Guideline, which only covered selected topics on the use of iodine-containing CM, a plan has been developed to make a set of 3 new guidelines covering the safe use of all types of CM in adults. The patient population for which these guidelines are meant consists of adult patients (>18 years) who receive intravascular, oral or intracavitary (intra-articular, intra-vesical, intra-cholangiographic) iodine-containing contrast media both in the clinical setting, as well as for outpatients. The guidelines do not cover radioactive contrast media use in nuclear medicine. The three parts of the Safe Use of Contrast Media guidelines will be produced in three consecutive 2-year projects and will cover the following topics regarding CM safety (part 3 is still in the planning phase, topics to be finalized): Safe Use of Contrast Media - Part 1 (2014-2017): - prevention of post-contrast acute kidney injury (PC-AKI) from iodine-containing contrast media; - iodine-containing contrast media use in patients with type-2 diabetes taking metformin; - iodine-containing contrast media use in patients on chronic dialysis. Safe Use of Contrast Media - Part 2 (2016-2019): - management of hypersensitivity reactions to contrast media; - prophylaxis of hypersensitivity reactions to contrast media & the role of skin testing in patients with hypersensitivity reactions; - contrast media injections with power injectors through (peripherally inserted) central venous lines and implantable ports; - contrast media extravasation; - nephrotoxicity of gadolinium-based contrast agents; - prevention of nephrogenic systemic fibrosis (NSF); - retention of gadolinium in the body after use of gadolinium-based contrast agents. Safe Use of Contrast Media - Part 3 (2018-2020; still in planning): - prevention of iodine-induced hyperthyroidism; - safety of organ-specific gadolinium-based contrast agents; - contrast media use in pregnancy and during lactation; - contrast media use in patients with pheochromocytoma; - contrast media use in patients with myasthenia gravis; - contrast media use in patients with mastocytosis; - the Weber and Lalli effects in using contrast media. 5 Guideline Safe Use of Contrast Media – Part 1 General Introduction Part 1 This first part will deal with one of the main challenges in the intravenous and intra- arterial use of CM, the prevention of contrast-induced nephropathy (CIN), also called contrast-induced acute kidney injury (CI-AKI). This issue has received large interest in recent years, resulting in strict prevention guidelines for all physicians requesting radiologic or cardiologic diagnostic or interventional studies with iodine-containing CM. The nephrotoxicity of gadolinium-based contrast media and/or microbubble contrast media and the recommendations for measurement of eGFR will be integrated with the guidelines for prevention of Nephrogenic Systemic Fibrosis. These recommendations will be published in the guideline Safe Use of Contrast Media, part 2 (due begin 2019). The mainstay of the current prevention protocols consists of intravenous volume expansion with either normal saline (NaCl 0.9%), lactated Ringer’s solution, or sodium bicarbonate (NaHCO3 1.4%), starting multiple hours before the administration of iodine- containing CM and continuing for multiple hours after iodine-containing CM administration. The time intervals for this preventive hydration normally range from 4- 12 hours before and 4-12 hours after iodine-containing contrast administration, but these may have to be individualized and prolonged in patients with severe congestive heart