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Completed

NCT Number: NCT02757443

Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

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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Key information

Conditions

Cardiac Surgical Procedures Heart Valve Prosthesis Implantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Evgeny Fominskiy

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phosphocreatine sodium tetrahydrate after anaesthesia induction

Drug

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

Other names: Neoton

5% Glucose after anaesthesia induction

Drug

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

Other names: Dextrose

Phosphocreatine sodium tetrahydrate added to cardioplegia

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)

Other names: Neoton

5% glucose

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)

Other names: Dextrose added to cardioplegia

Phosphocreatine sodium tetrahydrate after heart recovery

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

Other names: Neoton

5% Glucose after heart recovery

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

Other names: Dextrose

Phosphocreatine sodium tetrahydrate after ICU admission

Drug

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

Other names: Neoton

5% Glucose after ICU admission

Drug

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

Other names: Dextrose

Primary outcomes

  1. Peak concentration of Troponin I

    Time frame: From the randomization to the postoperative day 3 (POD 3)

Secondary outcomes

  1. The need for (yes/no), and dosage (inotropic score) of, inotropic agents

    Time frame: through study completion, an average of 4 weeks

  2. The need for (yes/no), the number of and the dosage of, defibrillation

    Time frame: through study completion, an average of 4 weeks

  3. The incidence of new-onset moderate and severe arrhythmias or cardiac arrest

    Time frame: through study completion, an average of 4 weeks

  4. Cardiac index

    Time frame: at 6 h after ICU admission, and at the beginning of POD 1

  5. Left ventricular ejection fraction

    Time frame: At the beginning of POD 1

  6. Peak serum creatinine concentration

    Time frame: through study completion, an average of 4 weeks

  7. The incidence of acute kidney injury

    Time frame: through study completion, an average of 4 weeks

  8. Sequential Organ Failure Assessment score

    Time frame: through study completion, an average of 4 weeks

  9. Duration of mechanical ventilation

    Time frame: through study completion, an average of 4 weeks

  10. Duration of ICU stay

    Time frame: through study completion, an average of 4 weeks

  11. Duration of hospital stay

    Time frame: through study completion, an average of 4 weeks

  12. 30-day all-cause mortality

    Time frame: 30 days after randomisation

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Acronym: PRISE

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 2, 2016
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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