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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03557255
Enrollment
60
Registered
2018-06-14
Start date
2017-08-01
Completion date
2018-04-23
Last updated
2018-06-14

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

Conditions

Heart Failure

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.

Interventions

DRUGLevosimendan

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

DRUGSaline

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

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in mechanical ventilationBaseline and after two weeksThe total duration of postoperative ventilation in days

Secondary

MeasureTime frameDescription
Patient total hospital length of stayBaseline and after two weeks postoperativeTotal hospital length of stay in days.
Changes in Ejection fractionBaseline and after one week postoperativeThe improvement in the ejection fraction in percentage.
Changes in cardiac indexBaseline and after one week postoperativeThe improvement in Cardiac index (Liters/minute/square meter)
Changes in Stroke volume indexBaseline and after one week postoperativeThe improvement in stroke volume index(milliliters/square meter)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026