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

2016YFC1301000

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.

2018-12-18

2022-10-22

2023-05-01

Completed

Early phase I

131

Inclusion Criteria for CRRT Study: 1. Patients receiving VA-ECMO support for any reason no longer than 24 hours 2. Provision of informed consent Exclusion Criteria for CRRT Study: 1. Age \< 18 years 2. Patients with convention indication of CRRT: AKI prior to enrollment caused by any reason, at least 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/12h) for more than 72 hours. 3. CKD with estimated GFR\<30 mL/min 4. Have already initiated CRRT 5. Active hemorrhage/thrombotic thrombocytopenic purpura 6. Respiratory failure has already initiated VV-ECMO or extracorporeal carbon dioxide removal device before the initiation of VA-ECMO of this time. 7. Prepared for heart transplant or patients received heart transplant. Inclusion Criteria for Beta-blocker Study: 1. Patients receiving VA-ECMO support for any reason. 2. Dopamine/dobutamine \<5 μg/kg/min, no administration of adrenaline or norepinephrine. 3. Within 7 days after initiation of VA-ECMO Exclusion Criteria for Beta-blocker Study: 1. Age \< 18 years 2. Contraindications or intolerance to beta-blockers * Moderate or severe bronchial asthma attack or history of bronchial asthma * Sinus bradycardia (heart rate \< 60 bpm) * Type II second-degree or third-degree AVB * Allergy to esmolol 3. For women at child bearing age, pregnant or positive pregnancy test. 4. Respiratory failure has already initiated VV-ECMO or extracorporeal carbon dioxide removal device before the initiation of VA-ECMO of this time 5. Have been on beta-blocker treatment after initiation of ECMO 6. Prepared for heart transplant or patients received heart transplant.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 131, 'type': 'ACTUAL'}}

2024-04-24