heart disease
Conditions
Interventions
Experimental group :The experimental group will receive HX-1 cardioplegic solution, manufactured by Chengdu Qingshan Likang Pharmaceuticals Corporation.The Experimental group will undergo cardiac arr
Control group:The control group will receive HTK solution (Custodiol HTK–Solution, National Medical Device Registration No. 20163103302), produced by DR. FRANZ KOEHLER CHEMIE GMBH. The control groups
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years, no gender restrictions; (2) Scheduled for elective open-heart surgery (including thoracoscopic cardiac surgery); (3) Requires cardiopulmonary bypass (CPB) with cardiac arrest during the procedure; (4) Understands the purpose of the trial, voluntarily agrees to participate, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Emergency surgery or heart transplantation. (2) History of previous cardiac surgery. (3) EuroSCORE II =10%. (4) Severe dysfunction of major organs such as liver or kidney, e.g., AST or ALT > 3 times the upper limit of normal (ULN), Scr > 3 times the ULN, or requiring dialysis. (5) History of acute myocardial infarction, myocarditis, or infective endocarditis within the past 2 weeks. (6) Left ventricular dysfunction (left ventricular ejection fraction, LVEF < 35%). (7) Cardiogenic shock with systolic blood pressure < 90 mmHg despite inotropic support. (8) Known or suspected allergy to components of the investigational device or drugs required for the procedure (e.g., lidocaine, insulin). (9) Implanted cardiac pacemaker or defibrillator. (10) Preoperative requirement for mechanical circulatory support such as IABP or ECMO. (11) Pregnant or breastfeeding women. (12) Severe psychiatric disorders preventing cooperation. (13) History of alcohol abuse or drug abuse. (14) Participation in other clinical trials. (15) Determined by the investigator to be unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cTnT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Creatine Kinase-MB;cardiac troponin I;rate of spontaneous cardiac recovery;rate of all-cause mortality up to discharge or postoperative day 30;change in left ventricular ejection fraction from baseline;need for intra-aortic balloon pump;need for extracorporeal membrane oxygenation;re-operation rate;timepoints of ICU admission and discharge;initial ICU stay; | — |
Countries
China
Contacts
Public ContactChengbin Zhou
Guangdong Provincial People's Hospital
Outcome results
None listed