Sodium Creatine Phosphate in Heart Valve Surgery

Study Overview
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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.

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

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Drug: sodium creatine phosphate
* Drug: saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sodium creatine phosphate<br>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<br>* sodium creatine phosphate .Loading dose followed by continuous infusion in operation<br>* Other names: Neoton;|
| Placebo Comparator: Control<br>The control group was treated with saline in the same manner. | Drug: saline<br>* .Loading dose followed by continuous infusion in operation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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