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Phosphocreatine for Myocardial Protection in High-Risk Cardiac Surgery
NCT02757443Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- Apr 2021
- Countries
- 1
- Sponsor
- E. Meshalkin National Medical Research Centre
- Modality
- Recombinant Proteins and Enzymes, Small Molecules
- Drugs
- phosphocreatine
- Conditions
- Myocardial injury
01
Overview
Phase 3, randomised, double-blind trial of phosphocreatine in Myocardial injury (2 arms), sponsored by E. Meshalkin National Medical Research Centre. Primary endpoint: Peak concentration of Troponin I. Started Jun 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Phosphocreatine
Experimental arm receiving phosphocreatine IV (induction, declamping, ICU) and in cardioplegia.
Control
Placebo arm receiving 5% Glucose IV and in cardioplegia.
03
Who it enrols
Adults with double or triple valve lesions requiring cardiac surgery with CPB, excluding those with emergency surgery, CABG, or significant kidney disease.
04
Endpoints
Primary
Peak concentration of Troponin I
Secondary
Need for and dosage of inotropic agents
Need for and dosage of defibrillation
Incidence of new-onset moderate and severe arrhythmias or cardiac arrest
Cardiac index
Left ventricular ejection fraction
Peak serum creatinine concentration
Incidence of acute kidney injury
Sequential Organ Failure Assessment
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