Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgical Procedures Heart Valve Prosthesis Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Phosphocreatine

Participants randomly assigned to the phosphocreatine arm receive:

* after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV);
* 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);
* 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;
* immediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV

Group Type EXPERIMENTAL

Phosphocreatine sodium tetrahydrate after anaesthesia induction

Intervention Type DRUG

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

Phosphocreatine sodium tetrahydrate added to cardioplegia

Intervention Type DRUG

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)

Phosphocreatine sodium tetrahydrate after heart recovery

Intervention Type DRUG

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

Phosphocreatine sodium tetrahydrate after ICU admission

Intervention Type DRUG

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

Control

Participants randomly assigned to the placebo arm receive:

* after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes;
* together with cardioplegia 50 mL of glucose 5% is added in every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany);
* 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;
* immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes

Group Type PLACEBO_COMPARATOR

5% Glucose after anaesthesia induction

Intervention Type DRUG

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

5% Glucose

Intervention Type DRUG

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

5% Glucose after heart recovery

Intervention Type DRUG

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

5% Glucose after ICU admission

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

5% Glucose after anaesthesia induction

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

Intervention Type 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)

Intervention Type 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)

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Neoton Dextrose Neoton Dextrose added to cardioplegia Neoton Dextrose Neoton Dextrose

Eligibility Criteria

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Inclusion Criteria

* Double/triple valve lesion that required cardiac surgery with CPB
* Aged 18 years or older
* Signed informed consent

Exclusion Criteria

* Emergency surgery
* Concomitant coronary artery bypass grafting surgery (CABG) or procedure on any part of the aorta
* Chronic kidney disease of G3-G4-G5 categories according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria (at least one of the following present for \> 3 months: glomerular filtration rate ≤ 60 ml/min/1.73 m2, history of kidney transplantation) or solitary kidney (by any reason)
* Known allergy to PCr
* Pregnancy
* Current enrollment into another RCT (in the last 30 days)
* Previous enrollment and randomisation into the PRISE trial
* Administration of PCr in the previous 30 day
* Concomitant radiofrequency/cryo- ablation procedure
* Structural abnormalities or genetic trait point to kidney disease including glomerulonephritis and gout.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No