Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

Heart Failure Clinical Trial

Official title:

The Role of Preoperative Use of Levosimendan in Ischemic Cardiac Patients Undergoing Major Abdominal Cancer Surgeries: A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557255
• Other study ID #: Ehab-Raafat.Levo
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: April 23, 2018

Study information

• Verified date: June 2018
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 23, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Levosimendan
Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.
• Saline
Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.

Locations

Country	Name	City	State
Egypt	Department of Anesthesia and Pain medicine.National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mechanical ventilation	The total duration of postoperative ventilation in days	Baseline and after two weeks
Secondary	Changes in Ejection fraction	The improvement in the ejection fraction in percentage.	Baseline and after one week postoperative
Secondary	Changes in cardiac index	The improvement in Cardiac index (Liters/minute/square meter)	Baseline and after one week postoperative
Secondary	Changes in Stroke volume index	The improvement in stroke volume index(milliliters/square meter)	Baseline and after one week postoperative
Secondary	Patient total hospital length of stay	Total hospital length of stay in days.	Baseline and after two weeks postoperative

External Links

•   Preconditioning effects of levosimendan in coronary artery bypass grafting—a pilot study.