Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation
Conditions
Keywords
Phosphocreatine, Creatine Phosphate, Neoton, Phosphate, Creatine, Phosphorylcreatine
Brief 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.
Interventions
DRUGPhosphocreatine 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)
DRUG5% Glucose after anaesthesia induction
after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
DRUGPhosphocreatine 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)
DRUG5% 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)
DRUGPhosphocreatine 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
DRUG5% 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
DRUGPhosphocreatine sodium tetrahydrate after ICU admission
immediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV
DRUG5% Glucose after ICU admission
immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak concentration of Troponin I | From the randomization to the postoperative day 3 (POD 3) |
Secondary
| Measure | Time frame |
|---|---|
| The need for (yes/no), the number of and the dosage of, defibrillation | through study completion, an average of 4 weeks |
| The incidence of new-onset moderate and severe arrhythmias or cardiac arrest | through study completion, an average of 4 weeks |
| Cardiac index | at 6 h after ICU admission, and at the beginning of POD 1 |
| Left ventricular ejection fraction | At the beginning of POD 1 |
| Peak serum creatinine concentration | through study completion, an average of 4 weeks |
| The need for (yes/no), and dosage (inotropic score) of, inotropic agents | through study completion, an average of 4 weeks |
| Sequential Organ Failure Assessment score | through study completion, an average of 4 weeks |
| Duration of mechanical ventilation | through study completion, an average of 4 weeks |
| Duration of ICU stay | through study completion, an average of 4 weeks |
| Duration of hospital stay | through study completion, an average of 4 weeks |
| 30-day all-cause mortality | 30 days after randomisation |
| The incidence of acute kidney injury | through study completion, an average of 4 weeks |
Countries
Russia
Outcome results
None listed