Evaluation of Early CRRT InTerventions in Patients With ECMO(ELITE)

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.

Conditions

• Cardiogenic Shock

Interventions

DEVICE

Simultaneous CRRT

The patients in the simultaneous CRRT group will receive CRRT within 24 hours after the initiation of ECMO support.

DEVICE

Conventional-indication CRRT

The patients in the conventional-indication group will not receive CRRT until the patient demonstrates AKI and fulfills any one of the criteria of the conventional CRRT indication.

DRUG

Esmolol

The patients in esmolol group will receive a continuous esmolol infusion in addition to the standard care.

DRUG

Standard care

The patients in control group will not receive any beta-blockers, including esmolol, unless the doctor thinks there's a strong indication.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Beijing Anzhen Hospital

  lead OTHER

Principal Investigators

• Jianzeng Dong, PhD., Md. · Beijing Anzhen Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-18

Primary Completion

2022-10-22

Completion

2023-05-01

Countries

• China

Study Locations