Clinical TrialID 6848

Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

NCT02757443

Cardiac Surgical Procedures|Heart Valve Prosthesis Implantation

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Record Fields

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Clinical Trial Id
6848
Evidence Id
6848
Core Evidence Id
6848
Source Clinical Trial Id
6839
Herb2 Clinical Trial Id
HBCT006839
Nct Id
NCT02757443
Title
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
Status
Completed
Phase
Phase 3
Study Result
No
Study Condition
Cardiac Surgical Procedures|Heart Valve Prosthesis Implantation
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
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
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
120
Outcome Measure
Peak concentration of Troponin I, From the randomization to the postoperative day 3 (POD 3)
Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation
Funded By
NETWORK
Location
Evgeny Fominskiy, Novosibirsk, 630055, Russian Federation
Other Id
PCr-in-CS
Start Date
2016-06
Primary Completion Date
2021-04
Completion Date
2021-05
First Posted
2016-05-02
Results First Posted
Last Update Posted
2021-07-01
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02757443
Title Cn
Title En
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
Bilingual Status
semi_complete