Clinical Study on the Efficacy and Safety of Dantrolene in Preventing Ischemia-Reperfusion Ventricular Arrhythmia in Patients Undergoing Open Heart Surgery

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500103210

Enrollment

Unknown

Registered

2025-05-27

Start date

2025-06-03

Completion date

Unknown

Last updated

2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial ischemia-reperfusion injury

Interventions

Experimental group:At the beginning of the first perfusion, 0.2 mg/kg of dantrolene sodium injection is added at one time to the myocardial protective solution through the Luer interface of the Weigao

Control group:Add an equal amount of sterile water for injection in the same manner.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1)Age between 18 and 70 years, regardless of gender. (2)Patients scheduled for cardiac valve replacement surgery under cardiopulmonary bypass (CPB). (3)Willingness to participate in the study and sign an informed consent form, and to accept follow-up.

Exclusion criteria

Exclusion criteria: (1) History of previous cardiac or major vascular surgery. (2) Diagnosis of infectious endocarditis. (3) Preoperative echocardiography showing left ventricular ejection fraction (LVEF) 120 U/L, creatinine >178 µmol/L. (7) Family history of malignant hyperthermia. (8) History of cardiopulmonary resuscitation. (9) Preoperative use of vasoactive medications. (10) Pregnancy or lactation. (11) Participation in any other clinical trial during the study period. (12) Any other factors determined by the investigators that would make the patient unsuitable for inclusion in the study.

Design outcomes

Primary

Measure	Time frame
The incidence of ventricular fibrillation within 15 minutes after the opening of the ascending aorta in patients undergoing cardiopulmonary bypass heart valve surgery.;	—

Secondary

Measure	Time frame
High-sensitivity cardiac troponin T (hs-cTnT);Myoglobin (MYO);CK-MB mass (CKMB);White blood cell count;Platelet count;Creatinine (Cr);Alanine Transaminase (ALT);Alanine Transaminase (AST);Cardiopulmonary Bypass Time (CPBT);Aortic Cross-Clamp Time (ACCT);Blood gas indicators;Mechanical ventilation time;Length of Stay in Intensive Care Unit (ICU);Case fatality rate: within 30 days after surgery;Left Ventricular Ejection Fraction (LVEF);	—

Measure

Time frame

High-sensitivity cardiac troponin T (hs-cTnT);Myoglobin (MYO);CK-MB mass (CKMB);White blood cell count;Platelet count;Creatinine (Cr);Alanine Transaminase (ALT);Alanine Transaminase (AST);Cardiopulmonary Bypass Time (CPBT);Aortic Cross-Clamp Time (ACCT);Blood gas indicators;Mechanical ventilation time;Length of Stay in Intensive Care Unit (ICU);Case fatality rate: within 30 days after surgery;Left Ventricular Ejection Fraction (LVEF);

—

Countries

China

Contacts

Public ContactLei Qian

Sichuan Academy of Medical Sciences ·Sichuan Provincial People's Hospital

leiqianggh@163.com+86 150 1318 9601

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026