BACKGROUND:Antioxidant drugs such as N-acetylcysteine (NAC) and ascorbic acid have been evaluated in interventional studies to prevent contrast-induced nephropathy (CIN), however, there are limited data on comparing either or both, with background of standard intravenous saline hydration versus the standard intravenous saline hydration alone in preventing CIN. METHODS: We conducted a single-center randomized trial among patients undergoing coronary angiography or percutaneous coronary intervention who hadserum creatinine ≥ 1.3 mg/dL or were on diabetes mellitus medication. Eligible patients were randomly assigned to one of the following 4 groups: (1) NAC, (2) ascorbic acid, (3) combination of both drugs, and (4) control group. Additionally, all the groups received the standard intravenous saline hydration. Creatinine was measured 4-5 days after procedure. RESULTS: A total of 243 patients were randomized; 62 to NAC, 57 toascorbic acid, 58 to both drugs, and 66 to placebo. The development of 0.5 mg/dL absolute increase of serum creatinine, 25% relative decrease of creatinine clearance, or either (CIN) were measured in the ascorbic acid group (3.6% for all), NAC group (6.8%, 3.4%, 8.5%, respectively), combined group (5.5%, 5.5%, 9.1%, respectively), and control group (6.2%, 6.2%, 7.7%, respectively). None of these differences were significant (P = 0.896 for serum creatinine, P = 0.863 for creatinine clearance, and P = 0.684 for CIN). CONCLUSIONS: In a cohort of patients at risk of developing CIN, we could not detect any significant benefit of the use of ascorbic acid, NAC, or a combination of both drugs over the standard hydration regimen in preventing CIN.
RCT Entities:
BACKGROUND: Antioxidant drugs such as N-acetylcysteine (NAC) and ascorbic acid have been evaluated in interventional studies to prevent contrast-induced nephropathy (CIN), however, there are limited data on comparing either or both, with background of standard intravenous saline hydration versus the standard intravenous saline hydration alone in preventing CIN. METHODS: We conducted a single-center randomized trial among patients undergoing coronary angiography or percutaneous coronary intervention who had serum creatinine ≥ 1.3 mg/dL or were on diabetes mellitus medication. Eligible patients were randomly assigned to one of the following 4 groups: (1) NAC, (2) ascorbic acid, (3) combination of both drugs, and (4) control group. Additionally, all the groups received the standard intravenous saline hydration. Creatinine was measured 4-5 days after procedure. RESULTS: A total of 243 patients were randomized; 62 to NAC, 57 to ascorbic acid, 58 to both drugs, and 66 to placebo. The development of 0.5 mg/dL absolute increase of serum creatinine, 25% relative decrease of creatinine clearance, or either (CIN) were measured in the ascorbic acid group (3.6% for all), NAC group (6.8%, 3.4%, 8.5%, respectively), combined group (5.5%, 5.5%, 9.1%, respectively), and control group (6.2%, 6.2%, 7.7%, respectively). None of these differences were significant (P = 0.896 for serum creatinine, P = 0.863 for creatinine clearance, and P = 0.684 for CIN). CONCLUSIONS: In a cohort of patients at risk of developing CIN, we could not detect any significant benefit of the use of ascorbic acid, NAC, or a combination of both drugs over the standard hydration regimen in preventing CIN.
Authors: Aart J van der Molen; Peter Reimer; Ilona A Dekkers; Georg Bongartz; Marie-France Bellin; Michele Bertolotto; Olivier Clement; Gertraud Heinz-Peer; Fulvio Stacul; Judith A W Webb; Henrik S Thomsen Journal: Eur Radiol Date: 2018-02-07 Impact factor: 5.315