Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

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

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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation

  lead NETWORK

Principal Investigators

• Evgeny V. Fominskiy, MD PhD · Academician EN Meshalkin Novosibirsk Research Institute of Circulation Pathology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2021-04-30

Completion

2021-05-31

Countries

• Russia

Study Locations