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Sodium Creatine Phosphate in Heart Valve Surgery

Primary Purpose

Heart Valve Diseases

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sodium creatine phosphate
saline
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Valve Diseases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMCRecruiting
  • Cardiovascular Institute and Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sodium creatine phosphate

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

serum cardiac troponin I(cTnI)
serum cardiac troponin I(cTnI)

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2017
Last Updated
January 30, 2018
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03186053
Brief Title
Sodium Creatine Phosphate in Heart Valve Surgery
Official Title
Cardioprotective Effects of Sodium Creatine Phosphate in Valve Surgery: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sodium creatine phosphate
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
The control group was treated with saline in the same manner.
Intervention Type
Drug
Intervention Name(s)
sodium creatine phosphate
Other Intervention Name(s)
Neoton
Intervention Description
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
.Loading dose followed by continuous infusion in operation
Primary Outcome Measure Information:
Title
serum cardiac troponin I(cTnI)
Description
serum cardiac troponin I(cTnI)
Time Frame
within 24 hours after aortic declamping
Secondary Outcome Measure Information:
Title
mortality
Description
death rate in hospital
Time Frame
within 30 postoperative days
Title
stroke
Description
defintion by surgeon
Time Frame
within 30 postoperative days
Title
blood filtration of kidney failure
Description
need for dialysis
Time Frame
within 30 postoperative days
Title
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
Description
heart failure requires mechanical assistance
Time Frame
within 30 postoperative days
Title
mechanical ventilation time
Description
ventilation
Time Frame
within 30 postoperative days
Title
arrhythmia
Description
Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments
Time Frame
within 30 postoperative days

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guyan WANG, M.D.
Phone
+86-13910985139
Email
13910985139@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongrong FANG, M.D
Phone
+86-15001391329
Email
fangzhongrong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guyan WANG, M.D.
Organizational Affiliation
Department of anesthesiology,Fuwai hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guyan WANG, M.D.
Phone
+86-13910985139
Email
13910985139@163.com
First Name & Middle Initial & Last Name & Degree
Guyan WANG, M.D.
Facility Name
Cardiovascular Institute and Fuwai Hospital
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guyan Wang, M.D.
Phone
86-10-88398082
Email
13910985139@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Sodium Creatine Phosphate in Heart Valve Surgery

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