Clinical guidelines to reduce the risk of contrast induced nephropathy

Transcription

1 Nephrology Subject: Objective: Prepared by: Consultation: Clinical guidelines to reduce the risk of contrast induced nephropathy To implement all possible measures to reduce the risk of nephropathy from intravascular contrast media. Trust wide. Dr K A Abraham, Consultant Nephrologist, Ext 8796 (office hours) Drs E O Grady and D White (Radiology), Mr F Torella (Vascular Surgery), Dr P Wong (Cardiology), Ms Anne Waddington (Renal pharmacist), Drs Gradden, Pandya, Wong, Thangavelu, Goldsmith (Nephrology) Approved by: Clinical Standards Group February 2011 Evidence Base: Rank: C Date of Issue: June 2011 Review Date: June 2013 Introduction/ Background: Contrast nephropathy can occur in any patient who receives intravenous or intra-arterial contrast. There are measures available to reduce this complication and should be targeted at those patients who have pre-existing risk factors. At the same time, the risk of contrast nephropathy should not delay imaging in emergency situations. This guideline is designed to help clinicians undertake such interventions in a safe and timely manner. Exceptions: Avoid IV fluids in patients who are volume overloaded. Avoid N Acetylcysteine [NAC] in patients with a history of allergic reactions to NAC. Continue nephrotoxic drugs if the risk of stopping them outweighs the risk of kidney injury and there are no safe alternatives. Page 1 of 8

2 Reduction of Contrast Nephropathy Risk: Emergency Imaging In any patient with known renal dysfunction and egfr < 60 ml/min, consider non-contrast imaging. If the use of iodinated contrast is unavoidable, employ the smallest effective dose of iso/hypo-osmolar, non-ionic contrast. If it is necessary to use Gadolinium as a contrast agent, use the smallest effective dose of a cyclic Gadolinium compound. Only hydration is required for Gadolinium studies, not NAC or Sodium bicarbonate. Space contrast studies at least 48 hrs apart. Stop all potential nephrotoxins for 48 hrs post procedure (if clinically appropriate). (eg NSAIDs, COX2 inhibitors, ACE inhibitors, angiotensin receptor blockers, diuretics, aminoglycosides) Metformin: Stop Metformin in patients with egfr <60ml/min for 48 hours after the procedure. In patients with egfr >60ml/min, Metformin should be withheld for 48 hours after the procedure if they have received more than 100mL contrast agent or if the intra-arterial route was used to administer the contrast. Stratify Risk According to renal function High Risk egfr < 45 ml/min or AKI If Renal Function not known and has risk factors. Treat as high risk. Obtain urgent U&Es Low Risk egfr 45-60ml/min No Can scan be delayed? Yes Oral hydration 2 litres per day 24 hrs pre to 24 hrs post procedure If scan with contrast is unavoidable; Give 1200mg oral NAC and 500mg oral NaHCO3 stat, If not overloaded give 250ml 0.9% Saline as a bolus before proceeding to imaging and continue Saline infusion at a rate of 1mL/kg/hour. If scan can be delayed; Start oral NAC 600 mg bd, oral NaHCO3 500 mg tds and intravenous 0.9% saline at 1 ml/kg/hour for 12 hours pre imaging High risk patients post imaging Continue IV 0.9% saline 1 ml/kg/hour for 12 hours post procedure (unless renal function previously unknown and subsequently checked and found to be normal). Give: Oral NAC 600 mg bd for 24 hours post imaging Oral NaHCO mg tds for 24 hours post imaging Review potential nephrotoxins 48 Hrs post imaging and consider restarting if renal function stable Check U&E's and egfr at 24 hours, 72 hours and 5 days post imaging Refer to Nephrology post imaging IF There is a rise in SeCr of >25micromol/L or drop in egfr of 25 ml/min or more. Or Regarding possible post procedure dialysis IF patient received Gadolinium and egfr < 30 ml/min Abbreviations NAC = N-Acetyl cysteine NaHCO 3 = Sodium Bicarbonate AKI = Acute Kidney Injury NAC is an unlicensed medication and will not be available outside pharmacy normal opening hours. If oral NAC is not available the intravenous preparation may be given orally at the same dose. If patient is nil by mouth give NAC 1gm intravenously in 100ml 0.9% saline on day of contrast and on the day post procedure. In place of 0.9% saline, give 1.26% NaHCO3 IV at a rate of 3 ml/kg/hr for one hour pre and 1ml/kg/hr for 6 hours post procedure and avoid oral NaHCO3. Page 2 of 8

3 Reduction of Contrast Nephropathy Risk Elective Imaging Applicable to any patient referred by an Aintree clinician for intravascular contrast iodinated or gadolinium [Except for iodinated contrast to study dialysis access or iodinated contrast in anuric dialysis patients] For Inpatients check U&E's within 1 week prior to procedure For Outpatients check U&E s within 1 month prior to procedure if any of the following apply; Age > 65 yrs, Diabetes Mellitus, Renal dysfunction, Nephrotic, Hypotension, Cardiac failure, Dehydration, Multiple Myeloma, Cirrhosis, Anaemia, Renal Transplant, Diuretics, Nephrotoxins, Se Albumin < 35 g/l, In any patient with known renal dysfunction and egfr < 60 ml/min, consider non contrast imaging. If the use of iodinated contrast is unavoidable, employ the smallest effective dose of iso/hypo-osmolar, non-ionic contrast. If it is necessary to use Gadolinium as a contrast agent, use the smallest effective dose of a cyclic Gadolinium compound. Only hydration is required for Gadolinium studies, not NAC or Sodium bicarbonate. Space contrast studies at least 48 hrs apart. Stop all potential nephrotoxins from 48 hrs pre to 48 hrs post procedure (if clinically appropriate). (eg NSAIDs, COX2 inhibitors, ACE inhibitors, angiotensin receptor blockers, diuretics, aminoglycosides) Metformin: Stop Metformin in patients with egfr <60ml/min for 48 hours before and for 48 hours after the procedure. In patients with egfr >60ml/min, Metformin should be withheld for 48 hours after the procedure if they have received more than 100mL contrast agent or if the intra-arterial route was used to administer the contrast. Stratify Risk High risk egfr <45ml/min or AKI If possible avoid Gadolinium contrast in high risk patients Low risk egfr 45-60ml/min Admit 24 Hrs before imaging If not overloaded give intravenous 0.9% saline at a rate of 1 ml/kg/hour for 12 hours pre and continue for 12 hours post imaging Start oral NAC 600 mg bd 24 hours before imaging and continue for 24 hours post imaging Start oral NaHCO3 500 mg tid for 24 hours before imaging and continue for 24 hours post imaging Check U&E's and egfr at 24 hours, 72 hours and 5 days post imaging Oral hydration 2 litres per day 24 hrs pre to 24 hrs post procedure Abbreviations NAC = N-Acetyl cysteine NaHCO 3 = Sodium Bicarbonate AKI = Acute Kidney Injury Refer to Nephrology post imaging IF There is a rise in SeCr of >25micromol/L or drop in egfr of 25 ml/min or more. Or Regarding possible post procedure dialysis IF patient received Gadolinium and egfr < 30 ml/min NAC is an unlicensed medication and will not be available outside pharmacy normal opening hours. If oral NAC is not available the intravenous preparation may be given orally at the same dose. If patient is nil by mouth give NAC 1gm intravenously in 100ml 0.9% saline on day of contrast and on the day post procedure. In place of 0.9% saline, give 1.26% NaHCO3 IV at a rate of 3 ml/kg/hr for one hour pre and 1ml/kg/hr for 6 hours post procedure and avoid oral NaHCO3. Page 3 of 8

4 Appendix A: Contrast Induced Nephropathy References: 1. Thomsen HS, Morcos SK. Contrast media and the kidney. European Society of Urogenital Radiology [ESUR] Guidelines. BJR 2003; 76: Metformin: Updated guidance for use in diabetics with renal impairment. BFCR(09)7 The Royal College of Radiologists, Kelly AM, Dwamena B, Cronin P, Bernstein SJ, Carlos RC. Meta-analysis: effectiveness of drugs for preventing contrast-induced nephropathy. Ann Int Med 2008; 148: Navaneethan SD, Singh S, Appasamy S, Wing RE, Sehgal AR. Sodium Bicarbonate Therapy for Prevention of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis. Am J Kidney Dis 2009; 53: Rydahl C, Thomsen HS, Marckmann P. High Prevalence of Nephrogenic Systemic Fibrosis in Chronic Renal Failure Patients Exposed to Gadodiamide, a Gadolinium-Containing Magnetic Resonance Contrast Agent. Investigative Radiol 2008; 43: Pannu N, Weibe N, Tonelli M. Prophylaxis strategies for contrast-induced nephropathy. JAMA 2006; 295: Nikolsky E, Aymong ED. Dangas G, Mehran R. Radiocontrast nephropathy: identifying the high-risk patient and the implications of exacerbating renal function. Rev Cardiovasc Med. 2003; 4(suppl 1):S7-S McCullough PA, Adam A. Becker CR, et al; CIN Consensus Working Panel. Epidemiology and prognostic implications of contrast-induced nephropathy. Am J Cardiol, 2006 Sep 16; 98(6A):5K-13K. Epub 2006 Eeb Weisbord SD, Chen H, Stone RA, et al. Associations of increases in serum creatinine with mortality and length of hospital stay after coronary angiography. J Am Soc Nephrol, 2006; 17(10): Epub 2006 Aug Nash K, Hafeez A, Hou S. Hospital-acquired renal insufficiency. Am J Kidney Dis 2002; 39: Parfrey PS, Griffiths SM, Barrett BJ et al. Contrast material-induced renal failure in patients with diabetes mellitus, renal insufficiency, or both. A prospective controlled study. N Engl J Med 1989; 320: Rich MW, Crecelius CA. Incidence, risk factors, and clinical course of acute renal insufficiency after cardiac catheterization in patients 70 years of age or older. A prospective study. Arch Intern Med 1990; 150: Rihal CS, Textor SC, Grill DE et al. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation 2002; 105: McCullough PA, Wolyn R, Rocher LL et al. Acute renal failure after coronary intervention: incidence, risk factors, and relationship to mortality. Am J Med 1997; 103: Gruberg L, Mintz GS, Mehran R, et al. The prognostic implications of further renal function deterioration within 48 h of interventional coronary procedures in patients with pre-existent chronic renal insufficiency. J Am Coll Cardiol. 2000; 36(5): Sam AD, Morasch MD, Collins J et al. Safety of gadolinium contrast angiography in patients with chronic renal insufficiency. J Vasc Surg 2003; 38: Page 4 of 8

5 17. Ergun I, Keven K, Uruc I et al. The safety of gadolinium in patients with stage 3 and 4 renal failure. Nephrol Dial Transplant 2006; 21: Nyman U, Elmstahl B, Leander P et al. Are gadolinium-based contrast media really safer than iodinated media for digital subtraction angiography in patients with azotemia? Radiology 2002; 223: Nephrogenic fibrosing dermopathy associated with exposure to gadolinium- containing contrast agents St. Louis, Missouri, MMWR 2007; 56: Deo, A, Fogel, M, Cowper, SE. Nephrogenic Systemic fibrosis: A population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol 2007; 2: Shabana, WM, Cohan, RH, Ellis, JH, et al. Nephrogenic systemic fibrosis: a report of 29 cases. AM J Roentgenol 2008; 190: Broome, DR, Girguis, MS, Baron, PW, et al. Gadodiamide-associated nephrogenic systemic fibrosis: why radiologists should be concerned. Am J Roentgenol 2007; 188: R Mehran and E Nikolsky. Contrast-induced nephropathy: Definition, epidemiology and patients at risk. Kidney Int 2006; 69, S11 S Mueller C, Buerkle G, Buettner HJ, et al. Prevention of contrast media associated nephropathy: randomized comparison of 2 hydration regimens in 1620 patients undergoing coronary angioplasty. Arch Intern Med 2002; 162(3): Trivedi, HS, Moore, H, Nasr, S, Aggarwal, K. A randomized prospective trial to assess the role of saline hydration on the development of contrast nephrotoxicity. Nephron 2003; 93:C Merten, GJ, Burgess, WP, Gray, LV, et al. Prevention of contrast induced nephropathy with sodium bicarbonate: a randomized controlled trial. JAMA 2004; 291: Maioli, M, Toso, A, Leoncini, M, et al. Sodium bicarbonate versus saline for the prevention of contrast induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. J Am Coll Cardiol 2008; 52: Kshirsagar, AV, Poole, C, Mottl, A, et al. N- acetylcysteine for the prevention of radiocontrast induced nephropathy: a meta- analysis of prospective trials. J Am Soc Nephrol 2004; 15: Fishbane, S. N-acetylcysteine in the prevention of contrast induced nephropathy. Clin J Am Soc Nephrol 2008; 3: Briguori, C, Airoldi, F, D Andrea, D, et al. Renal insufficiency following contrast media administration trial (REMEDIAL): a randomized comparison of 3 preventive strategies. Circulation 2007; 115: Okada, S, Katagriri, K, Kumazaki, T, Yokoyama, H. Safety of gadolinium contrast agent in haemodialysis patients. Acta Radiol 2001; 42: Joffe, P, Thomsem, HS, Meusel, M. Pharmacokinetics of gadodiamide injection in patients with severe renal insufficiency and patients undergoing haemodialysis or continuous ambulatory peritoneal dialysis. Acad Radiol 1998; 5: Murashima, M, Drott, HR, Carlow, D, et al. Removal of gadolinium by peritoneal dialysis. Clin Nephrol 2008; 69:368. Page 5 of 8

6 N-Acetylcysteine to prevent contrast induced nephropathy Departments of Pharmacy, Cardiology and Nephrology What is contrast induced nephropathy? Contrast induced nephropathy is an injury to the kidneys caused by some of the substances used to enhance x-ray images. These substances contain iodine and are called contrast materials. Contrast induced nephropathy usually occurs within hours of the x-ray procedure. The kidneys usually recover 7-10 days later but in some cases the damage to the kidneys may be longer lasting. How does N-Acetylcysteine help to prevent contrast induced nephropathy? N-Acetylcysteine is an antioxidant. It is thought that an antioxidant may prevent contrast induced nephropathy by neutralizing substances called free radicals which may be harmful to the kidneys. N-Acetylcysteine is an unlicensed medicine. What is an unlicensed medicine? The makers of medicines must ask the government for a Product Licence if they want to sell their medicine in the UK. They show the government s Medicines Regulatory Agency that the medicine works for the illness to be treated and that it does not have too many side effects. How are medicines tested? Medicines are tested in clinical trials which are carefully controlled tests to ensure medicines work and are safe. Pharmacy Department Lower Lane Liverpool L9 7AL Tel: Why don t all medicines have a licence? A common reason is that it is not cost effective for the makers to test the medicine for the particular illness. Is it safe for me to take NAC if it is not licensed? Yes. We believe that it is the best way of preventing CIN and that the drug is relatively safe (see section on side-effects) How is N-Acetylcysteine given? N-Acetylcysteine is available as a tablet. The usual dose for preventing contrast induced nephropathy is one 600mg tablet in the morning and evening on the day before and on the day of the x-ray. N-Acetylcysteine is also available as an injection. The injection can be given by mouth if the tablet is not available. Is there any reason why I should not take N-Acetylcysteine? You should not take N-Acetylcysteine if you have an allergy to N-Acetylcysteine. The tablets of N-Acetylcysteine also contain Microcrystalline cellulose, Lactose, Magnesium stearate, Maize starch, Sodium cyclamate and Saccharin. You should not take the tablets if you are allergic to any of these ingredients. Leaflet Name: N-Acetylcysteine Leaflet Lead Name: Anne Waddington, Renal Pharmacist Date Leaflet Developed: February 2011 Date Leaflet Approved: February 2011 Review Date: February 2013 Version No: 1 Page 6 of 8 Ref: 1293

7 What are the side effects of N-Acetylcysteine? Side effects of N-Acetylcysteine are rare and most people do not get any side effects at all. Occasional side effects (less than 1 in 100 people) Headache Tinnitus (ringing in the ears) Stomatitis (mouth ulcers) Rare side effects (less than 1 in 1000 people) Diarrhoea Vomiting Heartburn Nausea Possible increased bleeding Very rare side effects (less than 1 in people) Allergic type reactions Is there anything else that can be used to prevent contrast induced nephropathy? This will depend on how well your kidneys are functioning. Your doctors may suggest you take sodium bicarbonate capsules. They will make sure you are well hydrated before the x-ray procedure either by asking you to drink lots of fluids or by giving you fluids via a drip. Will N-Acetylcysteine definitely prevent harm to my kidneys from the x-ray contrast material? There is still a risk of harm to the kidneys from the x-ray contrast material but the risk will be reduced by use of a combination of N-Acetylcysteine, sodium bicarbonate and extra hydration tailored to suit your requirements. Further Information If you have any particular questions on taking this medicine you should speak to your doctor to ensure you fully understand the reasons why we recommend it. The following website provides comprehensive health information as provided by GPs and Nurses during consultations. Aintree University Hospitals NHS Foundation Trust is not responsible for the content of any material referenced in this leaflet that has not been produced and approved by the Trust. You will also be asked to stop taking drugs which may sometimes harm your kidneys. These include anti-inflammatory drugs (NSAIDS), and ACE inhibitors or Angiotensin receptor blockers. These should be stopped 48 hours before the x-ray procedure. If you are taking Metformin (an anti-diabetes medicine) this should be stopped 48 hours before the x-ray procedure. If your kidneys are ok 48 hours after the x-ray procedure these medicines will be restarted. Leaflet Name: N-Acetylcysteine Leaflet Lead Name: Anne Waddington, Renal Pharmacist Date Leaflet Developed: February 2011 Date Leaflet Approved: February 2011 Review Date: February 2013 Version No: 1 Page 7 of 8 Ref: 1293

8 If you require a special edition of this leaflet This leaflet is available in large print, Braille, on audio tape or disk and in other languages on request. Please contact Customer Services on: Telephone Textphone Fax [for the hearing impaired] Leaflet Name: N-Acetylcysteine Leaflet Lead Name: Anne Waddington, Renal Pharmacist Date Leaflet Developed: February 2011 Date Leaflet Approved: February 2011 Review Date: February 2013 Version No: 1 Page 8 of 8 Ref: 1293