Open Heart. 2026 Jul 9;13(2):e003963. doi: 10.1136/openhrt-2026-003963.
ABSTRACT
BACKGROUND: Extracorporeal membrane oxygenation (ECMO) is increasingly used to treat patients with severe cardiac and pulmonary failure but the complications of acute kidney injury and fluid overload are common. We aimed to determine whether the early initiation of continuous renal replacement therapy (CRRT) can reduce 30-day mortality in patients with ECMO.
METHODS: The Evaluation of early CRRT intervention in patients with ECMO study was an investigator-initiated, multicentre, randomised, open clinical trial of patients undergoing ECMO who were randomly assigned to early initiation of CRRT (within 24 hours after ECMO) or conventionally indicated initiation of CRRT. All participants received standard diagnostic and therapeutic procedures. The primary endpoint was the 30-day mortality. A sample size of 500 patients was estimated to provide 80% power and a two-sided α of 0.05 to detect a 20% relative reduction in 30-day mortality assuming a rate of 70% in the usual care group. The primary analysis was unadjusted.
RESULTS: The study stopped early due to feasibility. Of the 131 patients assessed for eligibility, 40 were excluded based on the inclusion and exclusion criteria. Of the 91 randomised patients, 46 were assigned to the early CRRT group and 45 were assigned to the usual care group. In the intervention group, 35 patients (76.1%) received CRRT within 24 hours post-ECMO implementation vs 15 patients (33.3%) in the usual care group. In the intention-to-treat analysis, the primary outcome occurred in 20 patients (43.5%) in the early CRRT group and 21 patients (46.7%) in the usual care group (HR 0.93, 95% CI 0.50 to 1.72; p=0.75). There was no significant difference in serious adverse events between the two groups (11 (25.6%) vs 9 (21.4%); OR 1.26, 95% CI 0.46 to 3.45; p=0.65).
CONCLUSIONS: Early implementation of CRRT in patients with ECMO showed no evidence of a difference in 30-day mortality compared with conventional initiation. However, the trial was substantially underpowered and clinically important benefits or harms cannot be excluded.
TRIAL REGISTRATION NUMBER: NCT03549923.
PMID:42425722 | DOI:10.1136/openhrt-2026-003963
