NCT02757443

Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure. Phosphocreatine plays an important part in the energy heart system. The investigators have just performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and matched studies that compared phosphocreatine with placebo or standard treatment in patients with coronary artery disease or chronic heart failure or in those undergoing cardiac surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved cardiac outcomes when compared to the control group, however, the quality of the included studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to investigate whether providing phosphocreatine compared to placebo improves the myocardial protection in high-risk patients scheduled for cardiac surgery and to determine the best research endpoint for future trials.

Conditions

• Cardiac Surgical Procedures
• Heart Valve Prosthesis Implantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2016-05-02
• Last updated: 2021-07-01

Locations

1 site across 1 country: Russia