Comparison Between Levosimendan and Adrenaline in CABG Patients

NCT05222256 | Completed

• 1 other identifier: Tee in open heart surgery
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare between levosimendan and adrenaline in patients with pre-existing impaired systolic function (EF 30-40%), undergoing elective on-pump CABG, as regards hemodynamics and echocardiographic parameters.

Conditions

Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Systolic function (EF) will be measured in both groups Levosemindan and Adrenaline in patients with low ejection fraction (30-40%), undergoing elective on pump Coronary Artery Bypass Graft (CABG).

  transesophageal echo (TEE) will be continuously used to monitor LV systolic and diastolic function during surgery and recordings will be made simultaneously with hemodynamic measurements. LV Ejection Fraction In the transgastric mid-papillary view, the echo machine will be switched to M-mode and the following measurements will be taken: o LV end-diastolic diameter o LV end-systolic diameter The machine will then calculate the LV ejection fraction according to Teich's method

  24 hour

Secondary Outcomes (3)

• LV Myocardial Performance (Tei) Index will be measured in both groups

  24 hour

• LV Stroke Volume and Cardiac Output will be measured in both groups

  24 hour

• LV diastolic function will be measured in both groups

  24 hour

Study Arms (2)

Group (L) levosimendan group

EXPERIMENTAL

Patients in this group will receive levosimendan (0.1 μg/kg/min) during re-warming of the patients.

Group (A) Adrenaline group

ACTIVE COMPARATOR

Patients in this group will receive Adrenaline (0.05 μg /kg/min) during re-warming of the patients.

Drug: Adrenaline

Interventions

Levosimendan DRUG

Patients in this group will receive levosimendan

Adrenaline DRUG

Patients in this group will receive Adrenaline

Group (A) Adrenaline group

Eligibility Criteria

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

You may qualify if:

• ischemic hear disease
• age 18 and 65 years
• low left ventricular function (ejection fraction 30 - 40%),
• elective coronary artery bypass grafting (CABG) surgery

You may not qualify if:

• Age over 65 years
• Patients with end organ failure (renal, liver)
• Associated significant valve lesions
• Uncontrolled diabetes mellitus
• Emergency surgery

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit university

Asyut, Asyut Governorate, 11511, Egypt

Location

MeSH Terms

Interventions

Simendan; Epinephrine

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: February 3, 2022
• Study Start: March 25, 2022
• Primary Completion: March 29, 2024
• Study Completion: May 25, 2024
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

EG (1)