AKIKI
Trial question
What is the role of early or delayed initiation strategies for RRT in critically ill patients who have AKI but no potentially life-threatening complication directly related to renal failure?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
34.3% female
65.7% male
N = 620
620 patients (213 female, 406 male)
Inclusion criteria: patients with severe AKI who required mechanical ventilation, catecholamine infusion, or both and did not have a potentially life-threatening complication directly related to renal failure
Key exclusion criteria: severe laboratory abnormalities: a BUN level > 112 mg/dL, a serum potassium concentration > 6 mmol/L (or > 5.5 mmol.L despite medical treatment), a pH < 7.15 in the context of either pure metabolic acidosis (PaCO2 < 35 mmHg) or mixed acidosis (PaCO2 of ≥ 50 mmHg without the possibility of increasing alveolar ventilation), and acute pulmonary edema due to fluid overload responsible for severe hypoxemia requiring an oxygen flow rate > 5 L/min to maintain a SpO2 > 95% or requiring a FiO2 > 50% in patients receiving mechanical ventilation and despite diuretic therapy
Interventions
N=312 early RRT (started immediately after randomization)
N=308 delayed RRT (initiated if at least one of the following criteria was met: severe hyperkalemia, metabolic acidosis, pulmonary edema, BUN level > 112 mg/dL, or oliguria for > 72 hours after randomization)
Primary outcome
Death at day 60
48.5
49.7
49.7 %
37.3 %
24.9 %
12.4 %
0.0 %
Early renal replacement therapy
Delayed renal replacement therapy
No significant difference ↔
No significant difference in death at day 60 (48.5% vs. 49.7%; HR 1.03, 95% CI 0.82 to 1.29)
Secondary outcomes
Significant increase in patients who received RRT (98% vs. 51%; RR 1.92, 95% CI 0.78 to 3.06)
Safety outcomes
No significant differences in rate of complications potentially related to AKI or RRT, with the exception of hypophosphatemia, which was more common in the early-strategy group.
Significant differences in catheter-related bloodstream infections (10% vs. 5%, p = 0.03).
Conclusion
In patients with severe AKI who required mechanical ventilation, catecholamine infusion, or both and did not have a potentially life-threatening complication directly related to renal failure, early RRT was not superior to delayed RRT with respect to death at day 60.
Reference
Gaudry S, Hajage D, Schortgen F et al. Initiation Strategies for Renal-Replacement Therapy in the Intensive Care Unit. N Engl J Med. 2016 Jul 14;375(2):122-33.
Open reference URL