Clinical trial NCT03557255: Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries
Official title: The Role of Preoperative Use of Levosimendan in Ischemic Cardiac Patients Undergoing Major Abdominal Cancer Surgeries: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Changes in mechanical ventilation
timeFrame: Baseline and after two weeks
Secondary outcomes:
measure: Changes in Ejection fraction
timeFrame: Baseline and after one week postoperative
measure: Changes in cardiac index
timeFrame: Baseline and after one week postoperative
measure: Changes in Stroke volume index
timeFrame: Baseline and after one week postoperative
measure: Patient total hospital length of stay
timeFrame: Baseline and after two weeks postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Anesthesia and Pain medicine.National Cancer Institute
Study officials:
affiliation: National Cancer Institute- Cairo University
name: Ehab H Shaker, MD
role: PRINCIPAL_INVESTIGATOR
References: