Summary
Contrast mediuminduced nephropathy (CIN) is a serious complication with increasing frequency and an unfavorable prognosis. Previous analyses of surrogate parameters have suggested beneficial effects of hemodialysis that are assessed in this randomized clinical trial.
We performed a prospective single-center trial in 424 consecutive patients with serum creatinine concentrations between 1.3– 3.5 mg/dl who underwent elective coronary angiography. Patients were randomized to one of three treatment strategies with all patients receiving pre- and postprocedural hydration: One group received no additional therapy, patients in the second group were hemodialyzed once, and the third group received oral N-acetylcysteine. The frequency of CIN (defined as an increase in serum creatinine ≥0.5 mg/dl) from 48 to 72 h after catheterization was 6.1% in the hydration-only group, 15.9% with hemodialysis treatment, and 5.3% in the N-ACC group (intention-to-treat analysis; P = 0.008). There were no differences between the treatment groups with regard to increased (≥ 0.5 mg/dl) serum creatinine concentrations after 30–60 days (4.8%, 5.1%, and 3.1%, respectively; P = 0.700). Analyses of long-term follow-up (range 63 to 1316 days) by Cox regressions models of the study groups found quite similar survival rates (P = 0.500). In contrast to other (retrospective) studies, long-term survival of patients with vs those without CIN within 72 h was not different, but patients who still had elevated creatinine concentrations at 30–60 days suffered from a markedly higher 2-year mortality (46% vs 17%, P = 0.002).
In conclusion, hemodialysis in addition to hydration therapy for the prevention of CIN provided no evidence for any outcome benefit but evidence for probable harm. Increased creatinine concentrations at 30–60 days, but not within 72 h, were associated with markedly reduced long-term survival.
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This study was supported by an unrestricted research grant to the Hospital of the University of Muenster from Schering AG, Berlin, Germany.
Preliminary results of this trial have been presented as a poster on the annual congress of the European Society of Cardiology in Berlin, 2002: Reinecke H, Dieckmann T, Fleiter J, Fobker M, Matzkies F, Harz C, Schaefer R (2002) Prevention of contrast media-induced renal failure after coronary angiography – First results of the "Diuresis vs Dialysis (DVD) Study". Eur Heart J 23(Abstr Suppl):701
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Reinecke, H., Fobker, M., Wellmann, J. et al. A randomized controlled trial comparing hydration therapy to additional hemodialysis or N-acetylcysteine for the prevention of contrast medium-induced nephropathy. Clin Res Cardiol 96, 130–139 (2007). https://doi.org/10.1007/s00392-007-0473-4
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DOI: https://doi.org/10.1007/s00392-007-0473-4