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
Stéphane Gaudry, David Hajage, Fréderique Schortgen 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