NCT00610350CompletedPhase 4
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial
University of Roma La Sapienza1 site in 1 country100 target enrollmentStarted: January 2005Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Length of ICU stay
Study Overview
Brief Summary
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥18 years
- •intention to perform first-time multi-vessel CABG
Exclusion Criteria
- •unstable angina
- •valvular disease
- •diabetes mellitus treated with sulphonylurea drugs
- •renal failure
- •severe hepatic disease
- •severe chronic obstructive pulmonary disease
- •a history of prior CABG surgery
- •recent myocardial infarction (MI) within the previous month
Arms & Interventions
L
Experimental
Intervention: levosimendan (Drug)
P
Experimental
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Length of ICU stay
Time Frame: two weeks
Secondary Outcomes
- Length of hospital stay(3 weeks)
- Tracheal intubation time(one week)
- Inotropic support over the first 7 days(one week)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Preoperative Levosimendan in CABG Patients With Poor LV FunctionCoronary Artery Bypass GraftingLeft Ventricular DysfonctionNCT02184819Assistance Publique - Hôpitaux de Paris335
Completed
Not Applicable
Preoperative Infusion of Levosimendan in Patients Undergoing Cardiac SurgeryCardiac DiseaseCardiac FailureCardiac SurgeryInotropesEjection FractionNCT04635293Aretaieion University Hospital100
Completed
Phase 2
Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer SurgeriesHeart FailureNCT03557255National Cancer Institute, Egypt60
Completed
Phase 4
Prophylactic Administration of Levosimendan in Patients Undergoing Coronary SurgeryCoronary Artery DiseaseNCT01318460AHEPA University Hospital32
Recruiting
Not Applicable
Impact of Levosimendan Preconditioning on Critical Care and In-hospital Lengths of Stay After Cardiac Surgery With Bypass SurgeryLevosimendanCardiac SurgeryCardiopulmonary BypassNCT05685537Central Hospital, Nancy, France120