A randomized controlled trial comparing hydration therapy to additional hemodialysis or N-acetylcysteine for the prevention of contrast medium-induced nephropathy: the Dialysis-versus-Diuresis (DVD) Trial.
Contrast medium-induced 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>or=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 (>or=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.
Reinecke
H
H
Department of Cardiology and Angiology, University Hospital of Muenster, Germany. hreinecke@gmx.net
Fobker
M
M
Wellmann
J
J
Becke
B
B
Fleiter
J
J
Heitmeyer
C
C
Breithardt
G
G
Hense
H-W
HW
Schaefer
R M
RM
D000111:Acetylcysteine / Q000008:administration & dosage / Q000627:therapeutic use*; D058186:Acute Kidney Injury / Q000097:blood / Q000139:chemically induced / Q000401:mortality / Q000517:prevention & control*; D000368:Aged; D015415:Biomarkers / Q000097:blood; D003287:Contrast Media / Q000009:adverse effects*; D017023:Coronary Angiography / Q000379:methods; D003404:Creatinine / Q000097:blood; D004231:Diuresis; D004232:Diuretics / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D005500:Follow-Up Studies; D016166:Free Radical Scavengers / Q000008:administration & dosage / Q000627:therapeutic use*; D005858:Germany; D006801:Humans; D007552:Isotonic Solutions; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D006435:Renal Dialysis / Q000379:methods; D016019:Survival Analysis
D015415:Biomarkers; D003287:Contrast Media; D004232:Diuretics; D016166:Free Radical Scavengers; D007552:Isotonic Solutions; D003404:Creatinine; D000111:Acetylcysteine