Sodium Creatine Phosphate in Heart Valve Surgery

January 30, 2018 updated by: Guyan Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study

To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery Methods: 250 patients undergoing valve surgery were randomly divided into experimental group and control group. 5g 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). The control group was treated with saline in the same manner. The cTnI level was measured at the corresponding time points. Hemodynamic indexes and postoperative complications were recorded.

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Cardiovascular Institute and Fuwai Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100037
        • Recruiting
        • Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
        • Contact:
        • Principal Investigator:
          • Guyan WANG, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • valvular disease patients requiring valvular replacement or repair surgery with cardiopulmonary bypass(CPB)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: sodium creatine phosphate
5g 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).
Drug: sodium creatine phosphate
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
Other Names:
  • Neoton
PLACEBO_COMPARATOR: Control
The control group was treated with saline in the same manner.
Drug: saline
.Loading dose followed by continuous infusion in operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum cardiac troponin I(cTnI)
Time Frame: within 24 hours after aortic declamping
serum cardiac troponin I(cTnI)
within 24 hours after aortic declamping

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: within 30 postoperative days
death rate in hospital
within 30 postoperative days
stroke
Time Frame: within 30 postoperative days
defintion by surgeon
within 30 postoperative days
blood filtration of kidney failure
Time Frame: within 30 postoperative days
need for dialysis
within 30 postoperative days
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
Time Frame: within 30 postoperative days
heart failure requires mechanical assistance
within 30 postoperative days
mechanical ventilation time
Time Frame: within 30 postoperative days
ventilation
within 30 postoperative days
arrhythmia
Time Frame: within 30 postoperative days
Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments
within 30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

  • Study Director: Guyan WANG, M.D., Department of anesthesiology,Fuwai hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2017

Primary Completion (ANTICIPATED)

July 1, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 10, 2017

First Posted (ACTUAL)

June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2018

Last Update Submitted That Met QC Criteria

January 30, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWT2017-ZX004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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