Study Description

The primary study hypothesis is that intensive renal support decreases mortality in critically ill patients with acute renal failure as compared to conventional management of renal replacement therapy. Secondary hypotheses are that intensive renal support in critically ill patients with acute renal failure will shorten the duration of ARF and decrease the incidence and duration of non-renal complications as compared to conventional management.

The study is a multi-center, prospective, randomized, parallel-group trial of two strategies for the management of renal support in acute renal failure in critically ill patients. Patients are eligible for the study if they have ARF clinically consistent with a diagnosis of acute tubular necrosis and if the primary treatment team is planning on initiating renal support. Patients with chronic kidney disease, and patients with acute renal failure not due to ATN are excluded. In addition, in order to exclude patients with relatively mild disease, in whom ATN is not associated with high mortality, patients are included only if they have evidence of at least one non-renal organ failure or the presence of sepsis.

Patients are randomized in a 1:1 ratio to be treated using either a strategy of intensive renal support or conventional management of renal replacement therapy for their ARF. In both arms of the study, dialysis is initiated using the same criteria. In the intensive therapy arm, renal support is provided for hemodynamically stable patients as intermittent hemodialysis on a 6-times per week basis (target delivered spKt/V of 1.2/treatment), as compared to a 3-times per week basis (target delivered spKt/V of 1.2/treatment) in the conventional therapy arm. For hemodynamically unstable patients, renal support is provided as continuous venovenous hemodiafiltration (dosed at 35 mL/kg/hr in the intensive dose arm and 20 mL/kg/hr in the conventional dose arm) or as sustained, low-efficiency dialysis (SLED) provided 6-times per week in the intensive therapy arm and 3-times per week in the conventional therapy arm. Protocol therapy is continued until renal function recovers or until day 28. Patients who remain dialysis dependent when ready for discharge from acute care, or after day 28, whichever comes first, are taken off of protocol treatment and are prescribed further dialysis at the discretion of their treating physician.

The primary study end-point is 60-day all-cause mortality. Secondary end-points include all-cause hospital mortality, 1-year all-cause mortality, and recovery of renal function. Duration of renal support, ICU and hospital length of stay, discharge to “home” not requiring dialysis, and the development and/or recovery of non-renal organ failure (assessed by SOFA organ system scores) during renal support will also be assessed. An economic analysis of the treatment strategies will also be performed.

Detailed Study Description (PDF, 107KB)
Complete Study Protocol