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Levosimendan in Congenital Cardiac Surgery

Primary Purpose

Congenital Cardiovascular Defects, Low Cardiac Output Syndrome

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Levosimendan
Milrinone
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Cardiovascular Defects focused on measuring cardiac surgery with cardiopulmonary bypass

Eligibility Criteria

1 Day - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support

Exclusion Criteria:

  • Patients with renal and/or hepatic dysfunction
  • Patients requiring inotropic support before their surgery
  • Septic patients

Sites / Locations

  • Cliniques Universitaires Saint Luc

Outcomes

Primary Outcome Measures

serum lactate

Secondary Outcome Measures

Full Information

First Posted
June 10, 2008
Last Updated
January 25, 2010
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT00695929
Brief Title
Levosimendan in Congenital Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cardiovascular Defects, Low Cardiac Output Syndrome
Keywords
cardiac surgery with cardiopulmonary bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Description
Intravenous injection
Intervention Type
Drug
Intervention Name(s)
Milrinone
Intervention Description
Intravenous injection
Primary Outcome Measure Information:
Title
serum lactate
Time Frame
12 h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patients undergoing complex cardiac surgery under cardiopulmonary bypass and requiring inotropic support Exclusion Criteria: Patients with renal and/or hepatic dysfunction Patients requiring inotropic support before their surgery Septic patients
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
17377079
Citation
De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3. Erratum In: Anesth Analg. 2007 Jun;104(6):1544. Dosage error in article text.
Results Reference
background
PubMed Identifier
16885788
Citation
Namachivayam P, Crossland DS, Butt WW, Shekerdemian LS. Early experience with Levosimendan in children with ventricular dysfunction. Pediatr Crit Care Med. 2006 Sep;7(5):445-8. doi: 10.1097/01.PCC.0000235251.14491.75. Erratum In: Pediatr Crit Care Med. 2007 Mar;8(2):197.
Results Reference
background
PubMed Identifier
15329162
Citation
Turanlahti M, Boldt T, Palkama T, Antila S, Lehtonen L, Pesonen E. Pharmacokinetics of levosimendan in pediatric patients evaluated for cardiac surgery. Pediatr Crit Care Med. 2004 Sep;5(5):457-62. doi: 10.1097/01.pcc.0000137355.01277.9c.
Results Reference
result

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Levosimendan in Congenital Cardiac Surgery

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