Cardiac Surgical ProceduresPhase 3PRISENCT02757443
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
A Phase 3 study testing Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction and Phosphocreatine sodium tetrahydrate added to cardioplegia in people with Cardiac Surgical Procedures and Heart Valve Prosthesis Implantation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgical Procedures, Heart Valve Prosthesis Implantation
- What is being tested?
- Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction and Phosphocreatine sodium tetrahydrate added to cardioplegia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2016to May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Double/triple valve lesion that required cardiac surgery with CPB
- Aged 18 years or older
- Signed informed consent
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial
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.
- Being tested
- Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction, Phosphocreatine sodium tetrahydrate added to cardioplegia, 5% Glucose, Phosphocreatine sodium tetrahydrate after heart recovery
- Keywords
- Phosphocreatine, Creatine Phosphate, Neoton, Phosphate, Creatine, Phosphorylcreatine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phosphocreatine sodium tetrahydrate after anaesthesia inductionDrug
Also called Neoton
after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV)
5% Glucose after anaesthesia inductionDrug
Also called Dextrose
after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
Phosphocreatine sodium tetrahydrate added to cardioplegiaDrug
Also called Neoton
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% GlucoseDrug
Also called Dextrose added to cardioplegia
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 recoveryDrug
Also called Neoton
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 recoveryDrug
Also called Dextrose
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 admissionDrug
Also called Neoton
immediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV
5% Glucose after ICU admissionDrug
Also called Dextrose
immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Phosphocreatine sodium tetrahydrate after anaesthesia induction; Drug: Phosphocreatine sodium tetrahydrate added to cardioplegia; Drug: Phosphocreatine sodium tetrahydrate after heart recovery; Drug: Phosphocreatine sodium tetrahydrate after ICU admission |
| 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 Receives: Drug: 5% Glucose after anaesthesia induction; Drug: 5% Glucose; Drug: 5% Glucose after heart recovery; Drug: 5% Glucose after ICU admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak concentration of Troponin I
Measured: From the randomization to the postoperative day 3 (POD 3)
Secondary outcomes (12)
The need for (yes/no), and dosage (inotropic score) of, inotropic agents
Measured: through study completion, an average of 4 weeks
The need for (yes/no), the number of and the dosage of, defibrillation
Measured: through study completion, an average of 4 weeks
The incidence of new-onset moderate and severe arrhythmias or cardiac arrest
Measured: through study completion, an average of 4 weeks
Cardiac index
Measured: at 6 h after ICU admission, and at the beginning of POD 1
Left ventricular ejection fraction
Measured: At the beginning of POD 1
Peak serum creatinine concentration
Measured: through study completion, an average of 4 weeks
The incidence of acute kidney injury
Measured: through study completion, an average of 4 weeks
Sequential Organ Failure Assessment score
Measured: through study completion, an average of 4 weeks
Duration of mechanical ventilation
Measured: through study completion, an average of 4 weeks
Duration of ICU stay
Measured: through study completion, an average of 4 weeks
Duration of hospital stay
Measured: through study completion, an average of 4 weeks
30-day all-cause mortality
Measured: 30 days after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Vladimir Lomivorotov, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Evgeny V. Fominskiy, MD PhD, Principal investigator, Academician EN Meshalkin Novosibirsk Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757443
- Sponsor's protocol ID
- PCr-in-CS
- Acronym
- PRISE
- Status last verified
- Jun 2021
- First submitted
- 13 Apr 2016
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 22071819Strumia 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.
PubMed 22297802Landoni 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.
PubMed 27318357Lomivorotov 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.
PubMed 38030971
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT02757443
- Acronym / sponsor ID
- PRISE / PCr-in-CS
- Keywords
- Phosphocreatine, Creatine Phosphate, Neoton, Phosphate, Creatine, Phosphorylcreatine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosphocreatine | Experimental | Drug: Phosphocreatine sodium tetrahydrate after anaesthesia induction, Drug: Phosphocreatine sodium tetrahydrate added to cardioplegia, Drug: Phosphocreatine sodium tetrahydrate after heart recovery, Drug: Phosphocreatine sodium tetrahydrate after ICU admissionParticipants 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 | Drug: 5% Glucose after anaesthesia induction, Drug: 5% Glucose, Drug: 5% Glucose after heart recovery, Drug: 5% Glucose after ICU admissionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Double/triple valve lesion that required cardiac surgery with CPB
- Aged 18 years or older
- Signed informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phosphocreatine sodium tetrahydrate after anaesthesia inductionAlso: Neotonafter anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV) | Drug | Phosphocreatine |
| 5% Glucose after anaesthesia inductionAlso: Dextroseafter anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes | Drug | Control |
| Phosphocreatine sodium tetrahydrate added to cardioplegiaAlso: Neotontogether 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) | Drug | Phosphocreatine |
| 5% GlucoseAlso: Dextrose added to cardioplegiatogether with cardioplegia 50 mL of glucose 5% is added in every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany) | Drug | Control |
| Phosphocreatine sodium tetrahydrate after heart recoveryAlso: Neotonimmediately 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 | Drug | Phosphocreatine |
| 5% Glucose after heart recoveryAlso: Dextroseimmediately 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 | Drug | Control |
| Phosphocreatine sodium tetrahydrate after ICU admissionAlso: Neotonimmediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV | Drug | Phosphocreatine |
| 5% Glucose after ICU admissionAlso: Dextroseimmediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes | Drug | Control |
Primary outcome
Peak concentration of Troponin I
Time frame: From the randomization to the postoperative day 3 (POD 3)
12 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
- Background: PubMed 22071819Horjus 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.
- Background: PubMed 22297802Strumia 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.
- Background: PubMed 27318357Landoni 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.
- Derived from this study: PubMed 38030971Lomivorotov 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny V. Fominskiy, MD PhD principal investigator
Academician EN Meshalkin Novosibirsk Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phosphocreatine sodium tetrahydrate after anaesthesia induction, 5% Glucose after anaesthesia induction and Phosphocreatine sodium tetrahydrate added to cardioplegia in people with Cardiac Surgical Procedures and Heart Valve Prosthesis Implantation, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak concentration of Troponin I (time frame: From the randomization to the postoperative day 3 (POD 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757443, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2021.