Levosimendan in Congenital Cardiac Surgery

Status Completed

Clinical Trial Summary

Many pediatric patients undergoing cardiac surgery under cardiopulmonary bypass for repair of complex congenital malformations, require inotropic support for low cardiac output syndrome. Milrinone through its positive inotropic and vasodilatory effects is widely used for this purpose. The aim of the study is to compare Milrinone with Levosimendan, a novel inotope with calcium-sensitizing properties. We hypothesized that using Levosimendan would result in reduced serum lactate through a higher cardiac index.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Cardiac Output, Low
Congenital Cardiovascular Defects
Low Cardiac Output Syndrome

Clinical Trial Details

NCT number	NCT00695929
Study type	Interventional
Source	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact
Status	Completed
Phase	N/A
Start date	July 2008
Completion date	October 2009

View Details

See also
Status	Clinical Trial	Phase
Unknown status	`NCT00549107` - Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants	Phase 2
Completed	`NCT04045340` - Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
Completed	`NCT00619281` - How Much Cardiac Output is Enough?	N/A
Completed	`NCT01576094` - Two Inodilators Postsurgery in Neonates	Phase 1/Phase 2
Completed	`NCT00994825` - Levosimendan in High Risk Patients Undergoing Cardiac Surgery	Phase 4
Completed	`NCT03143348` - Prognostic Markers of Inflammation in Infants Undergoing Cardiopulmonary Bypass
Completed	`NCT02025621` - Levosimendan in Patients With Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery On Cardiopulmonary Bypass	Phase 3
Completed	`NCT03661385` - Nitric Oxide During Bypass for Arterial Switch Operation	Phase 3
Completed	`NCT01120106` - Levosimendan Administration in Neonates With Transposition of the Great Arteries	Phase 2
Recruiting	`NCT03823781` - Prophylactic Use of Milrinone After Congenital Heart Surgery in Infants	Phase 3
Completed	`NCT01328912` - Remote Ischemic Preconditioning in High Risk Cardiovascular Surgery Patients	Phase 3
Recruiting	`NCT03558269` - Autologous Umbilical Cord Blood Treatment of Neonate With CHD	Phase 1/Phase 2
Recruiting	`NCT04405856` - Outcome of Patients Treated With IABP
Recruiting	`NCT04698005` - Exogenous Ketones for Acutely Decompensated HEart Failure	Phase 3
Active, not recruiting	`NCT05514652` - Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting	N/A
Recruiting	`NCT06355882` - Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia	N/A
Completed	`NCT03207165` - Milrinone Versus Dobutamine in Critically Ill Patients	Phase 4