IDEAL-ICU
Trial question
What is the role of early strategy for the initiation of RRT among patients with septic shock who had severe AKI?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 488
488 patients (192 female, 296 male).
Inclusion criteria: patients with early-stage septic shock who had severe AKI at the failure stage of the risk, injury, failure, loss, and end-stage kidney disease classification system but without life-threatening complications related to AKI.
Key exclusion criteria: requirement of emergency RRT before randomization, chronic renal at dialysis, moribund with life expectancy < 24 hours.
Interventions
N=246 an early strategy (RRT within 12 hours after documentation of failure-stage AKI).
N=242 a delayed strategy (RRT after a delay of 48 hours if renal recovery had not occurred).
Primary outcome
Death at 90 days
58%
54%
58.0 %
43.5 %
29.0 %
14.5 %
0.0 %
An early
strategy
A delayed
strategy
No significant
difference ↔
No significant difference in death at 90 days (58% vs. 54%; RR 1.07, 95% CI -1.29 to 3.43).
Secondary outcomes
Significant decrease in days free of RRT (12 days vs. 16 days; AD -4 days, 95% CI -6.85 to -1.15).
No significant difference in days free of mechanical ventilation (2 days vs. 3 days; AD -1 days, 95% CI -2.49 to 0.49).
No significant difference in median length of ICU stay (11 days vs. 10 days; AD 1 days, 95% CI -14.97 to 16.97).
Safety outcomes
No significant difference in other adverse events and fluid balance at any given time.
Significant difference in hyperkalemia (0% vs. 4%).
Conclusion
In patients with early-stage septic shock who had severe AKI at the failure stage of the risk, injury, failure, loss, and end-stage kidney disease classification system but without life-threatening complications related to AKI, an early strategy was not superior to a delayed strategy with respect to death at 90 days.
Reference
Saber D Barbar, Raphaël Clere-Jehl, Abderrahmane Bourredjem et al. Timing of Renal-Replacement Therapy in Patients with Acute Kidney Injury and Sepsis. N Engl J Med. 2018 Oct 11;379(15):1431-1442.
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