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You can access this
clinical trial
if you have
Cardiac Surgical Procedures or Heart Valve Prosthesis Implantation
and you are
over 18
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

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.

Provided treatments

  • Drug: Phosphocreatine sodium tetrahydrate after anaesthesia induction
  • Drug: 5% Glucose after anaesthesia induction
  • Drug: Phosphocreatine sodium tetrahydrate added to cardioplegia
  • Drug: 5% Glucose
  • Drug: Phosphocreatine sodium tetrahydrate after heart recovery
  • Drug: 5% Glucose after heart recovery
  • Drug: Phosphocreatine sodium tetrahydrate after ICU admission
  • Drug: 5% Glucose after ICU admission
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Tris trial is registered with FDA with number: NCT02757443. The sponsor of the trial is Meshalkin Research Institute of Pathology of Circulation and it is looking for 0 volunteers for the current phase.
Official trial title:
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial