Evaluation of Early CRRT InTerventions in Patients With ECMO(ELITE)
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Extracorporeal membrane oxygenation (ECMO) is of great value in supporting patients with
cardiac shock. More than 80% ECMO patients will develop renal catastrophe that continuous
renal replacement therapy (CRRT) is required. The evidence is conflict as to whether early
CRRT improves outcomes. Early CRRT before a definite indication developed may prevent side
effects of toxicity and fluid overload and therefore, bring survival benefit for the patient.
This hypothesis need to be tested in RCT.
Plasma catecholamine levels can be very high in patients under VA-ECMO, which maybe toxic to
the cardiac myocardium. Beta-blockers can antagonize the effects of catecholamine. In
patients with VA-ECMO, the protective effect of beta-blocker may improve the patients'
outcome. This hypothesis also need to be tested in RCT.
ELITE (Evaluation of Early CRRT and Beta-blocker InTerventions in Patients with ECMO) study
is a factorial designed RCT with the purpose to test the benefit of early CRRT and
beta-blocker in patients treated with V-A ECMO. In the CRRT arm, patients will be randomized
to simultaneous CRRT (not late than 24 hours after the initiation of ECMO) or routine therapy
(CRRT when indicated). In the beta-blocker arm, patients will be randomized to beta-blocker
treatment with a heart rate target of 75±5 bpm or routine therapy. The primary outcome is
all-cause mortality at 30 days. Patients discharged alive will be followed for 1 year. Data
of mortality and quality of life which are secondary outcomes of this study, will be
collected.
Phase:
Phase 4
Details
Lead Sponsor:
Beijing Anzhen Hospital
Collaborator:
The First Affiliated Hospital of Zhengzhou University