Sodium Creatine Phosphate in Heart Valve Surgery

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03186053
• Other study ID #: FWT2017-ZX004
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2017
• Last updated: January 30, 2018
• Start date: June 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2018
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Guyan WANG, M.D.
• Phone: +86-13910985139
• Email: 13910985139[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 31, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Drug:
• sodium creatine phosphate
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
• saline
.Loading dose followed by continuous infusion in operation

Locations

Country	Name	City	State
China	Cardiovascular Institute and Fuwai Hospital	Beijing
China	Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum cardiac troponin I(cTnI)	serum cardiac troponin I(cTnI)	within 24 hours after aortic declamping
Secondary	mortality	death rate in hospital	within 30 postoperative days
Secondary	stroke	defintion by surgeon	within 30 postoperative days
Secondary	blood filtration of kidney failure	need for dialysis	within 30 postoperative days
Secondary	extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support	heart failure requires mechanical assistance	within 30 postoperative days
Secondary	mechanical ventilation time	ventilation	within 30 postoperative days
Secondary	arrhythmia	Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments	within 30 postoperative days