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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV)
after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
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)
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 2 g of PCr prepared in 50 mL of glucose 5% during 30 min IV
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 4 g of PCr in 100 mL of glucose 5% during 60 min IV
immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes
Evgeny Fominskiy
Novosibirsk, Russia
Peak concentration of Troponin I
Time frame: From the randomization to the postoperative day 3 (POD 3)
The need for (yes/no), and dosage (inotropic score) of, inotropic agents
Time frame: through study completion, an average of 4 weeks
The need for (yes/no), the number of and the dosage of, defibrillation
Time frame: through study completion, an average of 4 weeks
The incidence of new-onset moderate and severe arrhythmias or cardiac arrest
Time frame: through study completion, an average of 4 weeks
Cardiac index
Time frame: at 6 h after ICU admission, and at the beginning of POD 1
Left ventricular ejection fraction
Time frame: At the beginning of POD 1
Peak serum creatinine concentration
Time frame: through study completion, an average of 4 weeks
The incidence of acute kidney injury
Time frame: through study completion, an average of 4 weeks
Sequential Organ Failure Assessment score
Time frame: through study completion, an average of 4 weeks
Duration of mechanical ventilation
Time frame: through study completion, an average of 4 weeks
Duration of ICU stay
Time frame: through study completion, an average of 4 weeks
Duration of hospital stay
Time frame: through study completion, an average of 4 weeks
30-day all-cause mortality
Time frame: 30 days after randomisation
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