Sodium Creatine Phosphate in Heart Valve Surgery

NCT ID: NCT03186053

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

sodium creatine phosphate

Intervention Type DRUG

sodium creatine phosphate .Loading dose followed by continuous infusion in operation

Control

The control group was treated with saline in the same manner.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

.Loading dose followed by continuous infusion in operation

Interventions

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sodium creatine phosphate

sodium creatine phosphate .Loading dose followed by continuous infusion in operation

Intervention Type DRUG

saline

.Loading dose followed by continuous infusion in operation

Intervention Type DRUG

Other Intervention Names

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Neoton

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guyan Wang

The Chief of Infection-Control Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guyan WANG, M.D.

Role: STUDY_DIRECTOR

Department of anesthesiology,Fuwai hospital

Locations

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Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC

Beijing, Beijing Municipality, China

Site Status RECRUITING

Cardiovascular Institute and Fuwai Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guyan WANG, M.D.

Role: CONTACT

Phone: +86-13910985139

Email: [email protected]

Zhongrong FANG, M.D

Role: CONTACT

Phone: +86-15001391329

Email: [email protected]

Facility Contacts

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Guyan WANG, M.D.

Role: primary

Guyan Wang, M.D.

Role: primary

Other Identifiers

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FWT2017-ZX004

Identifier Type: -

Identifier Source: org_study_id