Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries
Heart Failure
About this trial
This is an interventional prevention trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients suffering from CHF with left ventricular ejection fraction < 35%, scheduled for major abdominal cancer surgery were eligible.
- Aged 18 to 75 years.
Exclusion criteria were :
- restrictive or obstructive cardiomyopathy.
- severe cardiac valvular disease.
- history of atrial fibrillation, ventricular tachycardia or fibrillation.
- resting systolic arterial pressure <80 mmHg.
- second or third degree atrioventricular block.
- Child-Pugh class C liver cirrhosis.
- severe renal failure (defined as creatinine clearance < 30 ml/min).
- Immediate postoperative complications such as surgical re-exploration for bleeding or suspected leak.
Sites / Locations
- Department of Anesthesia and Pain medicine.National Cancer Institute
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
levosimendan
control
Levosimendan was prepared in a concentration of 25 µg/ml and infusion was commenced at a rate of 0.1 µg/kg/minute without loading and continued for 24 hours before surgery.The dose was doubled if an increase of > 20 mmHg in systolic blood pressure (SBP) could not be obtained within 2 hours after starting the infusion. Indications for dose reduction were the development of hypotension (SBP < 80 mmHg) or tachycardia (heart rate > 120 beats/min) persisting for more than 10 minute or (premature beats in a frequency exceeding 6/min or occurrence of a significant arrhythmia occurring in runs). The infusion medication would be discontinued should such occurrences persist despite dose reduction.
In the control group ,an identical saline infusion regimen was employed instead of levosimendan . Both patient and care giver were blinded for the study.