Effect of prophylactic intravenous amiodarone administration on reperfusion ventricular fibrillation after release of aortic cross-clamp in patients with left ventricular hypertrophy undergoing cardiopulmonary bypass surgery

Effect of amiodarone administration on ventricular fibrillation after release of aortic cross-clamp in patients with left ventricular hypertrophy

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035057

Enrollment

Unknown

Registered

2020-07-29

Start date

2020-08-01

Completion date

Unknown

Last updated

2020-08-03

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

Conditions

Reperfusion ventricular fibrillation

Interventions

amiodarone group:prophylactic intravenous amiodarone administration

control group:placebo control

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75 years; 2. Left ventricular hypertrophy: LVMI > 115g / m2 in male and 95g / m2 in female; 3. Patients undergoing open heart surgery under cardiopulmonary bypass; 4. Subjects of ASA grade I-III

Exclusion criteria

Exclusion criteria: 1. Patients who took class I and class III antiarrhythmic drugs before operation; 2. Patients with QTc >=480ms or QT >=500ms before operation; 3. Patients with LVEF < 30%; 4. Patients with pulmonary fibrosis; 5. Patients with thyroid dysfunction; 6. Patients with electrolyte disorder; 7. Patients with hepatic and renal insufficiency; 8. Patients with amiodarone allergy; 9. Patients with emergency operation; 10. Patients who underwent second thoracotomy.

Design outcomes

Primary

Measure	Time frame
the incidence rate of ventricular fibrillation;	—

Secondary

Measure	Time frame
the duration of ventricular fibrillation;the number and maximum energy of defibrillations needed to terminate ventricular fibbrillation;heart rate;mean arterial pressure;central venous pressure;cardiac index;	—

Countries

China

Contacts

Public ContactYin Fang

The First Affiliated Hospital of Nanjing Medical University

yitianfang@sian.cn+86 19951986268

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026