---
title: Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
nct_id: NCT02757443
overall_status: COMPLETED
phase: PHASE3
sponsor: Meshalkin Research Institute of Pathology of Circulation
study_type: INTERVENTIONAL
primary_condition: Cardiac Surgical Procedures
countries: Russia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02757443.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02757443"
ct_last_update_post_date: 2021-07-01
last_seen_at: "2026-05-12T06:47:04.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

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

**NCT ID:** [NCT02757443](https://clinicaltrials.gov/study/NCT02757443)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Meshalkin Research Institute of Pathology of Circulation
- **Conditions:** Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation
- **Start Date:** 2016-06
- **Completion Date:** 2021-05
- **CT.gov Last Update:** 2021-07-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Phosphocreatine** (EXPERIMENTAL) — Participants randomly assigned to the phosphocreatine arm receive:

* after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV);
* 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);
* 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 ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV
- **Control** (PLACEBO_COMPARATOR) — Participants randomly assigned to the placebo arm receive:

* after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes;
* 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 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes;
* immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes

## Interventions

- **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)
- **5% Glucose after anaesthesia induction** (DRUG) — after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
- **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)
- **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)
- **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
- **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
- **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
- **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

## Primary Outcomes

- **Peak concentration of Troponin I** _(time frame: From the randomization to the postoperative day 3 (POD 3))_

## Secondary Outcomes

- **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)_

## Locations (1)

- Evgeny Fominskiy, Novosibirsk, Russia

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.evgeny fominskiy|novosibirsk||russia` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02757443.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02757443*  
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