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Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial (NCT02757443)

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.
  • 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)
    • Neoton
  • Drug: 5% Glucose after anaesthesia induction
    after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
    • Dextrose
  • 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)
    • Neoton
  • 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)
    • Dextrose added to cardioplegia
  • 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
    • Neoton
  • 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
    • Dextrose
  • 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
    • Neoton
  • 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
    • Dextrose
Ages eligible for Study
18 Years and older
Genders eligible for Study
All
Accepts 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 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 ≤ 29 ml/min/1.73 m2, history of kidney transplantation)
  • 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

1 locations

Russian Federation (1)
  • Evgeny Fominskiy
    recruiting
    Novosibirsk, Russian Federation, 630055
Status:
recruiting
Type:
Interventional
Phase:
Start:
31 May, 2016
Updated:
19 September, 2017
Participants:
0
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