An interventional study of sodium creatine phosphate and saline in Heart Valve Diseases, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-31.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Not applicable, Interventional, and Supportive care
To explore the effect of intraoperative sodium creatine phosphate on myocardial protection in patients undergoing valve surgery
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.
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This study's planned enrollment of 250 is above the median of 100 across 291 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 141 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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
The control group was treated with saline in the same manner.
Drug: saline
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
Also known as: Neoton
.Loading dose followed by continuous infusion in operation
serum cardiac troponin I(cTnI)
serum cardiac troponin I(cTnI)
Time frame: within 24 hours after aortic declamping
mortality
death rate in hospital
Time frame: within 30 postoperative days
stroke
defintion by surgeon
Time frame: within 30 postoperative days
blood filtration of kidney failure
need for dialysis
Time frame: within 30 postoperative days
extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support
heart failure requires mechanical assistance
Time frame: within 30 postoperative days
mechanical ventilation time
ventilation
Time frame: within 30 postoperative days
arrhythmia
Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments
Time frame: within 30 postoperative days
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences, Fuwai Hospital