Comparison Between Levosimendan and Adrenaline in CABG Patients
Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study
1 other identifier
interventional
52
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2021
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedFebruary 8, 2022
February 1, 2022
2 years
December 6, 2021
February 6, 2022
Conditions
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
EXPERIMENTALPatients in this group will receive levosimendan (0.1 μg/kg/min) during re-warming of the patients.
Group (A) Adrenaline group
ACTIVE COMPARATORPatients in this group will receive Adrenaline (0.05 μg /kg/min) during re-warming of the patients.
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
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 1, 2022
Primary Completion
March 1, 2024
Study Completion
May 1, 2024
Last Updated
February 8, 2022
Record last verified: 2022-02