Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

Phase 2

Completed

• Conditions: Heart Failure
• Interventions: Drug: Saline; Drug: Levosimendan

• Registration Number: NCT03557255
• Lead Sponsor: National Cancer Institute, Egypt

Brief Summary

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.

Detailed Description

Cardiac complications are one of the most common causes of perioperative morbidity and mortality in patients undergoing non-cardiac surgery. Heart failure (HF) is an established risk factor for postoperative cardiac complications and mortality. The risk for postoperative mortality following major non-cardiac surgery is twice as that of patients with coronary artery disease (CAD) without HF. HF occurs in 1% to 6% of patients after major surgery, the risk being higher, between 6% and 25%, in patients with pre-existing cardiac conditions such as CAD, prior HF or valvular heart disease.

Cardiovascular disease and cancer are among the leading causes of mortality worldwide. The number of patients presenting with both diseases concomitantly is likely to increase. Cardiac patients undergoing major abdominal cancer surgeries with substantial fluid shift, blood loss and severe hemodynamic instability are at higher risk for perioperative HF.Therefore, preoperative optimization of such patients is of paramount importance. Unfortunately, guidelines for the perioperative management and preparation of such patients have not been proposed. Besides, the prophylactic use of inotropic agents for preoperative optimization of patients at high risk for HF remains controversial owing to their potential to jeopardize the myocardial oxygen supply-demand balance or to induce dysrhythmias with an assumed higher mortality.

Levosimendan is a calcium sensitizer with a positive inotropic action that has been shown to safely improve cardiac performance and hemodynamics in HF patients without increasing the myocardial oxygen demand or causing dysrrhythmias. The perioperative use of levosimendan for optimization of patients with HF has been reported in few studies with promising results, mainly for cardiac patients undergoing cardiac surgeries. However, the role of levosimendan has not been thoroughly evaluated in patients with chronic heart failure (CHF) undergoing major cancer surgery.

The purpose of this prospective study is to evaluate the safety and efficacy of preoperative administration of levosimendan in patients with CHF scheduled for major abdominal cancer surgery.

Study Timeline

• Study Start: 2017-08-01
• Primary Completion: 2018-02-01
• Study Completion: 2018-04-23
• Study First Submitted: 2018-05-10
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-13
• Last Update Submitted: 2018-06-13
• Study First Posted: 2018-06-14
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Saline	In the control group ,an identical saline infusion regimen was employed instead of levosimendan . Both patient and care giver were blinded for the study.
levosimendan	Levosimendan	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.

Primary Outcome Measures

Name	Time	Method
Changes in mechanical ventilation	Baseline and after two weeks	The total duration of postoperative ventilation in days

Secondary Outcome Measures

Name	Time	Method
Changes in Ejection fraction	Baseline and after one week postoperative	The improvement in the ejection fraction in percentage.
Changes in cardiac index	Baseline and after one week postoperative	The improvement in Cardiac index (Liters/minute/square meter)
Changes in Stroke volume index	Baseline and after one week postoperative	The improvement in stroke volume index(milliliters/square meter)
Patient total hospital length of stay	Baseline and after two weeks postoperative	Total hospital length of stay in days.

Trial Locations

Locations (1)

Department of Anesthesia and Pain medicine.National Cancer Institute; 🇪🇬 Cairo, Egypt