Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

NCT03557255 | Completed Phase 2

• 1 other identifier: Ehab-Raafat.Levo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Changes in mechanical ventilation

  The total duration of postoperative ventilation in days

  Baseline and after two weeks

Secondary Outcomes (4)

• Changes in Ejection fraction

  Baseline and after one week postoperative

• Changes in cardiac index

  Baseline and after one week postoperative

• Changes in Stroke volume index

  Baseline and after one week postoperative

• Patient total hospital length of stay

  Baseline and after two weeks postoperative

Study Arms (2)

levosimendan

ACTIVE COMPARATOR

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.

Drug: Levosimendan

control

ACTIVE COMPARATOR

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

Drug: Saline

Interventions

Levosimendan DRUG

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

Also known as: drug group

levosimendan

Saline DRUG

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

Also known as: control group

control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from CHF with left ventricular ejection fraction \< 35%, scheduled for major abdominal cancer surgery were eligible.
• Aged 18 to 75 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan; Sodium Chloride; Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 14, 2018
• Study Start: August 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: April 23, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)