Sodium Creatine Phosphate in Heart Valve Surgery

Not Applicable

• Conditions: Heart Valve Diseases
• Interventions: Drug: saline; Drug: sodium creatine phosphate

• Registration Number: NCT03186053
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-10
• Study First Posted: 2017-06-14
• Study Start: 2017-06-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-01-31
• Primary Completion: 2018-07-01
• Study Completion: 2018-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	saline	The control group was treated with saline in the same manner.
sodium creatine phosphate	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).

Primary Outcome Measures

Name	Time	Method
serum cardiac troponin I(cTnI)	within 24 hours after aortic declamping	serum cardiac troponin I(cTnI)

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Department of Anesthesiology ,Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS and PUMC; 🇨🇳 Beijing, Beijing, China

Cardiovascular Institute and Fuwai Hospital; 🇨🇳 Beijing, China