Sodium Creatine Phosphate in Heart Valve Surgery | NCT03186053

Studies
Sodium Creatine Phosphate in Heart Valve Surgery

NCT03186053

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Status

Unknown status

Last Update Posted

Jan 31, 2018Actual

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Heart Valve Diseases

Interventions

sodium creatine phosphate
saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2017Actual

Primary Completion Date

Jul 1, 2018Estimated

Completion Date

Dec 31, 2018Estimated

First Submitted Date

May 29, 2017

First Submission Date that Met QC Criteria

Jun 10, 2017

First Posted Date

Jun 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Jan 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guyan Wang, The Chief of Infection-Control Department, Chinese Academy of Medical Sciences, Fuwai HospitalPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical Sciences, Fuwai HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sodium creatine phosphate	Experimental	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
Control	Placebo Comparator	The control group was treated with saline in the same manner.	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sodium creatine phosphate	Drug	sodium creatine phosphate .Loading dose followed by continuous infusion in operation	sodium creatine phosphate

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
mortality	death rate in hospital	within 30 postoperative days
stroke	defintion by surgeon	within 30 postoperative days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Guyan WANG, M.D.	Contact	+86-13910985139		13910985139@163.com
Zhongrong FANG, M.D	Contact	+86-15001391329		fangzhongrong@163.com

Overall Officials

Name	Affiliation	Role
Guyan WANG, M.D.	Department of anesthesiology,Fuwai hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC	Recruiting	Beijing	Beijing Municipality	100037	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010725	Phosphocreatine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D003401	Creatine
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D019606	Phosphoamino Acids

Browse Leaves

Not provided

Browse Branches

Not provided