Evaluation of Early CRRT InTerventions in Patients With ECMO(ELITE) (ELITE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03549923|
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : September 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiogenic Shock||Device: Simultaneous CRRT Device: Conventional-indication CRRT Drug: Esmolol Drug: Standard care||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Early CRRT Intervention in Patients Receiving VA-ECMO Support on 30-day Mortality: A Randomized Controlled Trial|
|Actual Study Start Date :||December 18, 2018|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Simultaneous CRRT group
CRRT is initiated simultaneously (not late than 24 hours from the initiation of ECMO treatment), regardless of presentation of conventional indication of CRRT. CRRT lasts for 12 hours or more is recommended.The physician can decide when to withdraw CRRT based on the patient's condition.
Device: Simultaneous CRRT
The patients in the simultaneous CRRT group will receive CRRT within 24 hours after the initiation of ECMO support.
Experimental: Conventional-indication CRRT group
CRRT is not initiated unless conventional indication of CRRT is presented. The conventional indication of CRRT is as follow: KDIGO stage 3 AKI and one of the following criteria is met: severe hyperkalemia (> 6.5 mmol/L), metabolic acidosis (pH < 7.2), pulmonary edema, blood urea nitrogen level >112 mg/dL, or oliguria (urine output < 200 mL/12 h) for more than 72 hours.
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.
Experimental: Esmolol group
Patients will receive a continuous esmolol infusion in addition to routine management. The esmolol infusion commences at 25 mg/h and increases by 25 mg/h every 20-minute until the maximal tolerate dosage is reached or the heart rate reduced to 75±5 bpm, or an upper dose limit of 2000 mg/h is reached. Continue infusing esmolol to maintain the heart rate threshold or at the discretion of the physician until either ICU discharge or death. Oral beta-blockers should be considered before the withdrawal of esmolol.
The patients in esmolol group will receive a continuous esmolol infusion in addition to the standard care.
Experimental: Control group
All beta-blockers, including esmolol, should not be used during ICU treatment, unless the doctor thinks there's a strong indication.
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.
- All-cause mortality [ Time Frame: 30 days ]
- All-cause mortality [ Time Frame: 365 days ]
- Proportion of patients receiving long-term RRT [ Time Frame: 365 days/when patient dies ]
- Success rate of weaning from ECMO [ Time Frame: 30 days ]Success weaning from ECMO is defined as survive > 24 hours after weaning
- Any serious adverse events (SAEs) [ Time Frame: 30 days ]Including bleeding, severe arrhythmias, ventilator associated pneumonia, hemorrhagic infection, surgical site infection, any reason induced limb ischemia, stroke and any adverse events that the physician regards as serious.
- EQ-5D score [ Time Frame: 365 days ]
- Duration stay at ICU and hospital [ Time Frame: 365 days ]
- Unplanned readmission to hospital [ Time Frame: 30 days ]
- Cause-specific mortality [ Time Frame: 365 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549923
|Contact: Jianzeng Dong, PhD., Md.||86 email@example.com|
|Contact: Xiaotong Hou, PhD., Md.||86 firstname.lastname@example.org|
|Principal Investigator:||Jianzeng Dong, PhD., Md.||Beijing Anzhen Hospital|