Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

NCT ID: NCT03557255

Last Updated: 2018-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2018-04-23

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Levosimendan

Intervention Type: DRUG

Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.

control

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

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: DRUG

Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.

Interventions

Levosimendan

Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.

Intervention Type: DRUG

Saline

Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.

Intervention Type: DRUG

Other Intervention Names

drug group; control group

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ehab Hanafy Shaker

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab H Shaker, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute- Cairo University

Locations

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Ehab-Raafat.Levo

Identifier Type: -

Identifier Source: org_study_id