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 755 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.
Extracorporeal membrane oxygenation (ECMO) is of great value in supporting patients with severe cardiopulmonary failure, but the mortality rate is still high.
Acute kidney injury (AKI) and fluid overload (FO) are the leading causes of death in patients under Veno-arterial (VA) ECMO. Continuous renal replacement therapy (CRRT) is an effective way to remove toxic substances and provide fluid management. According to current guidelines, CRRT is withhold until 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. However, fluid overload and metabolic disorders may cause irreversible damage to the patient and therefore increase mortality. The hypothesis of ELITE study is that simultaneous CRRT may provide better fluid management and avoid metabolic disorders, and bring survival benefit in VA-ECMO patients.
Patients under VA-ECMO are critically ill with high plasma catecholamine levels and treatment of various inotropic agents, which are toxic to the failed myocardium. Beta-blockers can antagonize the effects of endogenous and exogenous catecholamines. The hypothesis of ELITE study is that beta-blocker may protect the failing heart function and reduce 30-day mortality.
Study design:
ELITE study is a prospective, multi-centered, open, 22 factorial randomized controlled clinical trial.
In the simultaneous CRRT versus conventional-indication CRRT arm, patients under VA-ECMO will be randomized to the following 2 groups:
In the Beta-blocker versus routine therapy arm, patients with a maintaining dosage of dopamine/dobutamine <5 g/kg/min, and with neither epinephrine nor norepinephrine will be randomized to the following 2 groups:
Primary outcome: All-cause mortality at 30 days.
Secondary outcomes:
Sample size consideration:
The sample size calculations are based on the following hypothesis: (a) an estimate 30-day mortality of 70% in the control group; (b) a 20% relative risk reduction for each intervention alone (simultaneous CRRT and beta-blocker); (c) no loss to follow-up; (d) no interaction of the two interventions.
For each intervention, we calculated that a sample size of 496 patients would be required, 248 patients for the treatment group and 248 patients for the control group. In the 2 2 factorial design, patients will be randomized to one of four arms, the sample size of each would be 124 patients. With a crossover rate of 10%, the study will randomize 548 patients, 137 patients per arm.
Condition | Cardiogenic shock |
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Treatment | Standard Care, Esmolol, Simultaneous CRRT, Conventional-indication CRRT |
Clinical Study Identifier | NCT03549923 |
Sponsor | Beijing Anzhen Hospital |
Last Modified on | 17 May 2022 |
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