Earlier-Start Versus Usual-Start Dialysis in Patients With Community-Acquired Acute Kidney Injury: A Randomized Controlled Trial

Background: Optimum timing of the initiation of dialysis therapy in acute kidney injury is not clear. Study Design: Prospective, open label, 2-arm, randomized, controlled trial. Setting & Participants: 208 adults with acute kidney injury with progressively worsening azotemia at the artificial kidney dialysis unit of a tertiary-care referral center in western India. Intervention: Earlier-start dialysis was initiated when serum urea nitrogen and/or creatinine levels increased to 70 and 7 mg/dL, respectively, whereas the usual-start dialysis patients (control group) received dialysis when clinically indicated as judged by treating nephrologists. Outcomes: Primary outcome was in-hospital mortality and dialysis dependence at 3 months. Secondary outcome in patients receiving dialysis was time to recovery of kidney function, computed from time of enrollment to the last dialysis session. Results: Of 585 screened patients, 102 were assigned to earlier-start dialysis, and 106 to usual-start dialysis. Baseline characteristics were similar between randomized groups. 93 (91.1%) and 88 (83.1%) participants received dialysis in the intervention and control groups, respectively. Mean serum urea nitrogen and serum creatinine levels at dialysis therapy initiation were 71.7 +/- 21.7 (SD) and 7.4 +/- 5.3 mg/dL, respectively, in the intervention group versus 100.9 +/- 32.6 and 10.41 +/- 3.3 mg/dL in the control group. Data on primary outcome were available for all patients. In-hospital mortality was 20.5% and 12.2% in the intervention and control groups, respectively (relative risk, 1.67; 95% CI, 0.88-3.17; P = 0.2). 4.9% and 4.7% of patients in the intervention and control groups, respectively, were dialysis dependent at 3 months (relative risk, 1.04; 95% CI, 0.29-3.7; P = 0.9). Limitations: Study was not double blind, event rate (ie, mortality) was less than predicted, wide CIs preclude definitive findings. Conclusions: Our data do not support the earlier initiation of dialysis therapy in community-acquired acute kidney injury. (C) 2013 by the National Kidney Foundation, Inc.