Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

April 30, 2021

Study Completion Date

May 31, 2021

Conditions
Cardiac Surgical ProceduresHeart Valve Prosthesis Implantation
Interventions
DRUG

Phosphocreatine sodium tetrahydrate after anaesthesia induction

after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV)

DRUG

5% Glucose after anaesthesia induction

after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes

DRUG

Phosphocreatine sodium tetrahydrate added to cardioplegia

together with cardioplegia 2.5 g of PCr prepared in 50 mL of glucose 5% and added to every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany; concentration = 10 mmol/L)

DRUG

5% Glucose

together with cardioplegia 50 mL of glucose 5% is added in every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany)

DRUG

Phosphocreatine sodium tetrahydrate after heart recovery

immediately after heart recovery (spontaneous or paced myocardium contraction) after aorta declamping 2 g of PCr prepared in 50 mL of glucose 5% during 30 min IV

DRUG

5% Glucose after heart recovery

immediately after heart recovery (spontaneous or paced myocardium contraction) after aorta declamping 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes

DRUG

Phosphocreatine sodium tetrahydrate after ICU admission

immediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV

DRUG

5% Glucose after ICU admission

immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes

Trial Locations (1)

630055

Evgeny Fominskiy, Novosibirsk

All Listed Sponsors
lead

Meshalkin Research Institute of Pathology of Circulation

NETWORK

NCT02757443 - Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients | Biotech Hunter | Biotech Hunter