6/28/23, 12:05 AM AKIKI Pathway Feedback Search Clinical Topics Home Studies AKIKI AKIKI Disease Acute kidney injury 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 N = 620 65.7% male 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 (arterial partial pressure of CO2 < 35 mmHg) or mixed acidosis (arterial partial pressure of CO2 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 https://web.pathway.md/studies/recNYXANggvmC3bpn 1/2 6/28/23, 12:05 AM AKIKI Pathway 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 49.7 % 49.7 48.5 37.3 % 24.9 % 12.4 % No significant difference 0.0 % Early renal replacement therapy Delayed renal replacement therapy 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 https://web.pathway.md/studies/recNYXANggvmC3bpn 2/2