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Trial question
What is the effect of intensive renal support in critically ill patients with AKI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 1124
1124 patients (331 female, 793 male).
Inclusion criteria: critically ill patients with AKI and failure of at least one nonrenal organ or sepsis.
Key exclusion criteria: > 1 hemodialysis treatment or > 24 hours of continuous RRT, prior kidney transplant, pregnancy, moribund state, acute renal failure due to an etiology other than acute tubular necrosis, or weight > 128.5 kg.
Interventions
N=563 intensive RRT (intermittent hemodialysis and sustained low-efficiency dialysis six times per week and continuous venovenous hemodiafiltration at 35 mL/kg of body weight per hour).
N=561 less-intensive RRT (the corresponding treatments provided thrice weekly and at 20 mL/kg/hr).
Primary outcome
Death at 60 days
53.6%
51.5%
53.6 %
40.2 %
26.8 %
13.4 %
0.0 %
Intensive renal replacement therapy
Less-intensive renal replacement therapy
No significant difference ↔
No significant difference in death at 60 days (53.6% vs. 51.5%; OR 1.09, 95% CI 0.86 to 1.4).
Secondary outcomes
Borderline significant decrease in the rate of recovery of kidney function by day 28 (24.3% vs. 27.4%; OR 0.03, 95% CI 0.02 to 0.07).
No significant difference in in-hospital death (51.2% vs. 48%; OR 1.15, 95% CI 0.9 to 1.47).
Borderline significant increase in RRT-free days (6 vs. 7).
Safety outcomes
No significant differences in serious adverse event (51.0% vs. 49.9%, p=0.72) and hypotension requiring treatment discontinuation (9.8% vs. 8.7%, p=0.55).
Significant differences in hypokalemia (7.5% vs. 4.5%, p = 0.03) and hypophosphatemia (17.6% vs. 10.9%, p = 0.001).
Conclusion
In critically ill patients with AKI and failure of at least one nonrenal organ or sepsis, intensive RRT was not superior to less-intensive RRT with respect to death at 60 days.
Reference
VA/NIH Acute Renal Failure Trial Network, Paul M Palevsky, Jane Hongyuan Zhang et al. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20.
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