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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phosphocreatine | Experimental | Participants randomly assigned to the phosphocreatine arm receive:
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| Control | Placebo Comparator | Participants randomly assigned to the placebo arm receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration of Troponin I | From the randomization to the postoperative day 3 (POD 3) |
| Measure | Description | Time Frame |
|---|---|---|
| The need for (yes/no), and dosage (inotropic score) of, inotropic agents | through study completion, an average of 4 weeks | |
| The need for (yes/no), the number of and the dosage of, defibrillation | through study completion, an average of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evgeny V. Fominskiy, MD PhD | Academician EN Meshalkin Novosibirsk Research Institute of Circulation Pathology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evgeny Fominskiy | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22071819 | Background | Horjus DL, Oudman I, van Montfrans GA, Brewster LM. Creatine and creatine analogues in hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2011 Nov 9;2011(11):CD005184. doi: 10.1002/14651858.CD005184.pub2. | |
| 22297802 | Background | Strumia E, Pelliccia F, D'Ambrosio G. Creatine phosphate: pharmacological and clinical perspectives. Adv Ther. 2012 Feb;29(2):99-123. doi: 10.1007/s12325-011-0091-4. |
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|
| 5% Glucose after anaesthesia induction | Drug | after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes |
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| 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) |
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| 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) |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| 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 incidence of acute kidney injury | 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 |
| 27318357 | Background | Landoni G, Zangrillo A, Lomivorotov VV, Likhvantsev V, Ma J, De Simone F, Fominskiy E. Cardiac protection with phosphocreatine: a meta-analysis. Interact Cardiovasc Thorac Surg. 2016 Oct;23(4):637-46. doi: 10.1093/icvts/ivw171. Epub 2016 Jun 17. |
| 38030971 | Derived | Lomivorotov V, Merekin D, Fominskiy E, Ponomarev D, Bogachev-Prokophiev A, Zalesov A, Cherniavsky A, Shilova A, Guvakov D, Lomivorotova L, Lembo R, Landoni G. Myocardial protection with phosphocreatine in high-risk cardiac surgery patients: a randomized trial. BMC Anesthesiol. 2023 Nov 29;23(1):389. doi: 10.1186/s12871-023-02341-4. |
| ID | Term |
|---|---|
| D010725 | Phosphocreatine |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D003401 | Creatine |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D019606 | Phosphoamino Acids |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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