Clinical trial · Interventional
Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries
The Role of Preoperative Use of Levosimendan in Ischemic Cardiac Patients Undergoing Major Abdominal Cancer Surgeries: A Prospective Randomized Study
NCT03557255CI-TRIAL-00033304completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this pilot study is to evaluate the efficacy and safety of preoperative administration of levosimendan in patients with chronic heart failure scheduled for major abdominal cancer surgery assuming the reduction of both perioperative morbidity and mortality.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Levosimendan | Drug | — | UNRESOLVED |
| Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- levosimendan
- description
- 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.
- interventionNames
- Drug: Levosimendan
- type
- ACTIVE_COMPARATOR
- label
- control
- description
- In the control group ,an identical saline infusion regimen was employed instead of levosimendan . Both patient and care giver were blinded for the study.
- interventionNames
- Drug: Saline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.