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Comparison between theophylline, N-acetylcysteine, and theophylline plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

ABSTRACT: BACKGROUND:Few studies compared the efficacy of theophylline with N-acetylcysteine or evaluated the efficacy of combination therapy in the prevention of contrast-induced nephropathy (CIN). We compared the efficacy of theophylline, N-acetylcysteine, and the combination of these agents in the prevention of CIN. METHODS:This randomized controlled trial was conducted on 96 patients referring consecutively to the Shahid Chamran University Hospital in Isfahan, Iran, for elective coronary angiography (with our without angioplasty). Patients with at least moderate risk for CIN were included and were randomized to receive theophylline (200 mg), N-acetylcysteine (600 mg), or theophylline + N-acetylcysteine, twice a day, from 24 h before to 48 h after administration of the contrast material. A non-ionic, low-osmolar contrast material was used. Serum creatinine was measured before and 48 h after contrast material injection. RESULTS:Serum creatinine was increased by 6.83 ± 15.32% with theophylline, 13.09 ± 14.63% with N-acetylcysteine, and 5.45 ±1 3.96% with theophylline + N-acetylcysteine after contrast material injection (between group P = 0.072). Controlling for Mehran risk score, baseline serum creatinine, and contrast volume, the change in serum creatinine level was lower with theophylline compared with N-acetylcysteine (F = 4.79, P = 0.033), and with theophylline + N-acetylcysteine compared with N-acetylcysteine (F = 5.78, P = 0.020). CIN (increase in creatinine of ? 0.5 mg/dl or ? 25% from the baseline) was occurred in 20%, 21.9%, and 7.1% of patients in the theophylline, N-acetylcysteine, and theophylline + N-acetylcysteine groups, respectively (P = 0.260). CONCLUSION:Theophylline is superior to N-acetylcysteine in preventing contrast-induced renal dysfunction, but the combination with N-acetylcysteine is not superior to theophylline alone in this regard. Further trials with larger sample of patients are warranted.

SUBMITTER: Arabmomeni M

PROVIDER: S-EPMC4460352 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Comparison between theophylline, N-acetylcysteine, and theophylline plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Arabmomeni Morteza M Najafian Jamshid J Abdar Esfahani Morteza M Samadi Mohsen M Mirbagher Leila L

ARYA atherosclerosis 20150101 1

<h4>Background</h4>Few studies compared the efficacy of theophylline with N-acetylcysteine or evaluated the efficacy of combination therapy in the prevention of contrast-induced nephropathy (CIN). We compared the efficacy of theophylline, N-acetylcysteine, and the combination of these agents in the prevention of CIN.<h4>Methods</h4>This randomized controlled trial was conducted on 96 patients referring consecutively to the Shahid Chamran University Hospital in Isfahan, Iran, for elective coronar ...[more]

PMID: 26089930

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Project description:BackgroundContrast-induced nephropathy (CIN) is one of the common causes of acute renal insufficiency after contrast procedures. Whether intravenous N-acetylcysteine (NAC) is beneficial for the prevention of contrast-induced nephropathy is uncertain. In this meta-analysis of randomized controlled trials, we aimed to assess the efficacy of intravenous NAC for preventing CIN after administration of intravenous contrast media.Study designRelevant studies published up to September 2012 that investigated the efficacy of intravenous N-acetylcysteine for preventing CIN were collected from MEDLINE, OVID, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, and the conference proceedings from major cardiology and nephrology meetings. The primary outcome was CIN. Secondary outcomes included renal failure requiring dialysis, mortality, and length of hospitalization. Data were combined using random-effects models with the performance of standard tests to assess for heterogeneity and publication bias. Meta-regression analyses were also performed.ResultsTen trials involving 1916 patients met our inclusion criteria. Trials varied in patient demographic characteristics, inclusion criteria, dosing regimens, and trial quality. The summary risk ratio for contrast-induced nephropathy was 0.68 (95% CI, 0.46 to 1.02), a nonsignificant trend towards benefit in patients treated with intravenous NAC. There was evidence of significant heterogeneity in NAC effect across studies (Q = 17.42, P = 0.04; I(2) = 48%). Meta-regression revealed no significant relation between the relative risk of CIN and identified differences in participant or study characteristics.ConclusionThis meta-analysis showed that research on intravenous N-acetylcysteine and the incidence of CIN is too inconsistent at present to warrant a conclusion on efficacy. A large, well designed trial that incorporates the evaluation of clinically relevant outcomes in participants with different underlying risks of CIN is required to more adequately assess the role for intravenous NAC in CIN prevention.

Project description:Contrast-induced nephropathy (CIN) is a major complication of imaging in patients with chronic kidney disease (CKD). The publication of an academic randomized controlled trial (RCT; n = 83) reporting oral (N)-acetylcysteine (NAC) to reduce CIN led to > 70 clinical trials, 23 systematic reviews, and 2 large RCTs showing no benefit. However, no mechanistic studies were conducted to determine how NAC might work; proposed mechanisms included renal artery vasodilatation and antioxidant boosting. We evaluated the proposed mechanisms of NAC action in participants with healthy and diseased kidneys. Four substudies were performed. Two randomized, double-blind, placebo-controlled, three-period crossover studies (n = 8) assessed the effect of oral and intravenous (i.v.) NAC in healthy kidneys in the presence/absence of iso-osmolar contrast (iodixanol). A third crossover study in patients with CKD stage III (CKD3) (n = 8) assessed the effect of oral and i.v. NAC without contrast. A three-arm randomized, double-blind, placebo-controlled parallel-group study, recruiting patients with CKD3 (n = 66) undergoing coronary angiography, assessed the effect of oral and i.v. NAC in the presence of contrast. We recorded systemic (blood pressure and heart rate) and renal (renal blood flow (RBF) and glomerular filtration rate (GFR)) hemodynamics, and antioxidant status, plus biomarkers of renal injury in patients with CKD3 undergoing angiography. Primary outcome for all studies was RBF over 8 hours after the start of i.v. NAC/placebo. NAC at doses used in previous trials of renal prophylaxis was essentially undetectable in plasma after oral administration. In healthy volunteers, i.v. NAC, but not oral NAC, increased blood pressure (mean area under the curve (AUC) mean arterial pressure (MAP): mean difference 29 h⋅mmHg, P = 0.019 vs. placebo), heart rate (28 h⋅bpm, P < 0.001), and RBF (714 h⋅mL/min, 8.0% increase, P = 0.006). Renal vasodilatation also occurred in the presence of contrast (RBF 917 h⋅mL/min, 12% increase, P = 0.005). In patients with CKD3 without contrast, only a rise in heart rate (34 h⋅bpm, P = 0.010) and RBF (288 h⋅mL/min, 6.0% increase, P = 0.001) occurred with i.v. NAC, with no significant effect on blood pressure (MAP rise 26 h⋅mmHg, P = 0.156). Oral NAC showed no effect. In patients with CKD3 receiving contrast, i.v. NAC increased blood pressure (MAP rise 52 h⋅mmHg, P = 0.008) but had no effect on RBF (151 h⋅mL/min, 3.0% increase, P = 0.470), GFR (29 h⋅mL/min/1.73m², P = 0.122), or markers of renal injury. Neither i.v. nor oral NAC affected plasma antioxidant status. We found oral NAC to be poorly absorbed and have no reno-protective effects. Intravenous, not oral, NAC caused renal artery vasodilatation in healthy volunteers but offered no protection to patients with CKD3 at risk of CIN. These findings emphasize the importance of mechanistic clinical studies before progressing to RCTs for novel interventions. Thousands were recruited to academic clinical trials without the necessary mechanistic studies being performed to confirm the approach had any chance of working.

Dataset Information

Comparison between theophylline, N-acetylcysteine, and theophylline plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Publications

Comparison between theophylline, N-acetylcysteine, and theophylline plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Similar Datasets

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