Sodium Creatine Phosphate in Heart Valve Surgery
Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
1 other identifier
interventional
250
1 country
2
Brief Summary
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 14, 2017
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJanuary 31, 2018
January 1, 2018
1 year
May 29, 2017
January 30, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
serum cardiac troponin I(cTnI)
serum cardiac troponin I(cTnI)
within 24 hours after aortic declamping
Secondary Outcomes (6)
mortality
within 30 postoperative days
stroke
within 30 postoperative days
blood filtration of kidney failure
within 30 postoperative days
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
within 30 postoperative days
mechanical ventilation time
within 30 postoperative days
- +1 more secondary outcomes
Study Arms (2)
sodium creatine phosphate
EXPERIMENTAL5g creatine phosphate was dissolved in 50ml saline solution. After induction of anesthesia, the patients were first given a load dose of 1g, 20min (30ml / h) , And then pumped at a rate of 1 g / h (10 ml / h).
Control
PLACEBO COMPARATORThe control group was treated with saline in the same manner.
Interventions
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
Eligibility Criteria
You may qualify if:
- valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)
You may not qualify if:
- thoracoscopic valve surgery
- other organ dysfunction: such as cancer, organ failure, severe anemia, infection
- patients with mental disorders
- coagulopathy, active ulcer, ischemic or hemorrhagic stroke (within 6 months), trauma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
Beijing, Beijing Municipality, 100037, China
Cardiovascular Institute and Fuwai Hospital
Beijing, 100037, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guyan WANG, M.D.
Department of anesthesiology,Fuwai hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- The Chief of Infection-Control Department
Study Record Dates
First Submitted
May 29, 2017
First Posted
June 14, 2017
Study Start
June 15, 2017
Primary Completion
July 1, 2018
Study Completion
December 31, 2018
Last Updated
January 31, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share