CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 131 enrolled
Drug / intervention
Esmolol +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03549923
NCT03549923Phase 4Completed

Impact of Early CRRT Intervention in Patients Receiving VA-ECMO Support on 30-day Mortality: A Randomized Controlled Trial

Beijing Anzhen Hospital·interventional·Posted Jun 8, 2018·Updated Apr 24, 2024

In Brief

A Phase 4 clinical trial evaluating Simultaneous CRRT, Conventional-indication CRRT, and 2 other interventions for Cardiogenic Shock. Completed, enrolled 131 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 8, 2018
Enrollment StartDec 18, 2018
Primary CompletionOct 22, 2022
Study CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 8.1 years ago

Interventions

Simultaneous CRRTdevice

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

Conventional-indication CRRTdevice

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.

Esmololdrug

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

Standard caredrug

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