Heart Valve Diseases
Conditions
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.
Interventions
DRUGsodium creatine phosphate
sodium creatine phosphate .Loading dose followed by continuous infusion in operation
DRUGsaline
.Loading dose followed by continuous infusion in operation
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| serum cardiac troponin I(cTnI) | within 24 hours after aortic declamping | serum cardiac troponin I(cTnI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| stroke | within 30 postoperative days | defintion by surgeon |
| blood filtration of kidney failure | within 30 postoperative days | need for dialysis |
| mortality | within 30 postoperative days | death rate in hospital |
| mechanical ventilation time | within 30 postoperative days | ventilation |
| arrhythmia | within 30 postoperative days | Atrial fibrillation or Ventricular fibrillation or Ventricular tachycardia requiring drug treatments |
| extracorporeal membrane oxygenation (ECMO) or intraaortic balloon counterpulsation (IABP) support | within 30 postoperative days | heart failure requires mechanical assistance |
Countries
China
Contacts
Primary ContactGuyan WANG, M.D.
Backup ContactZhongrong FANG, M.D
Outcome results
None listed