"Renal-Replacement Therapy in Septic Shock with Acute Kidney Injury". The New England Journal of Medicine. ClinicalTrials.gov number, NCT01682590.
Links to original sources: Wiki Journal Post Full Journal Article
In patients with early-stage septic shock and severe acute kidney injury (AKI) without life-threatening complications, does early initiation of renal-replacement therapy within 12 hours offer a mortality benefit over initiation after 48 hours?
Early initiation of renal-replacement therapy in septic shock patients with severe AKI showed no significant difference in 90-day mortality compared to a strategy in which renal-replacement therapy was delayed for 48 hours.
The optimal timing for initiating renal-replacement therapy in the setting of septic shock associated with AKI remains uncertain. While immediate initiation is indicated during life-threatening complications related to AKI, such as hyperkalemia or metabolic acidosis, the benefits of early initiation in the absence of such complications are unclear. The IDEAL-ICU trial aimed to determine if early initiation of renal-replacement therapy would improve 90-day mortality compared to a strategy in which initiation was delayed.
The IDEAL-ICU trial was a multicenter, randomized, controlled trial including patients with severe AKI in the early stages of septic shock. The trial compared mortality rates between those receiving renal-replacement therapy within 12 hours of documented AKI and those in whom therapy was delayed by 48 hours if spontaneous recovery had not occurred. The trial found no mortality benefit at 90 days with early initiation versus a delayed strategy, prompting early termination due to futility. In the delayed-strategy group, 38% of patients did not receive renal-replacement therapy due to spontaneous recovery of renal function.
As of the completion of the IDEAL-ICU trial, no definitive guidelines had been established for the specific timing of renal-replacement therapy initiation in septic shock patients based on these results.
Multicenter, randomized, controlled, open-label trial N=488 patients with early-stage septic shock and severe AKI Early initiation of renal-replacement therapy within 12 hours (n=239) Delayed initiation after 48 hours without recovery (n=238) Mean follow-up: 90 days Primary outcome: All-cause mortality at 90 days
Inclusion Criteria: Patients ≥18 years old within 48 hours of septic shock and vasopressor therapy onset, with severe AKI classified as "failure" stage by RIFLE criteria Exclusion Criteria: Immediate need for emergency renal-replacement therapy before randomization Baseline Characteristics: Comparable between both groups concerning demographics and clinical parameters
Early strategy: Renal-replacement initiated within 12 hours after AKI documentation Delayed strategy: Initiated after 48 hours delay if no spontaneous recovery and no emergency criteria developed
Primary Outcome: No significant difference in mortality at 90 days (early: 58%, delayed: 54%, P=0.38) Secondary Outcomes: No significant differences in secondary outcomes, including 28-day and 180-day mortality, days free of renal-replacement therapy, and length of stay in ICU or hospital
- The adoption of the RIFLE classification which may not be as sensitive as KDIGO classification for identifying patients with AKI. - A delayed strategy of only 48 hours may not be long enough to determine clear differences between early and delayed initiation of renal-replacement therapy.
The trial was funded by the French Ministry of Health.
- Original publication of the IDEAL-ICU trial and accompanying editorial commentaries in The New England Journal of Medicine.