Renal failure preventive effect of levosimendan, a cardiac stimulant medication, in cardiac surgery in children with congenital heart disease

• Conditions: Acute kidney injury postoperatively in connection with surgery for congenital heart disease; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-003105-25-FI
• Lead Sponsor: Sahlgrenska University Hospital / The Queen Silvia Children´s Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-31
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1.Provision of informed consent prior to any study specific procedures
2.Female and male children between 1 and 12 months of age
3.Non-restrictive VSD (corrective surgery)
4.Complete AVSD (biventricular repair)
5.Tetralogy of Fallot
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Unbalanced AVSD
2.Age less than one month and more than one year
3.acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
4.Pre-existing renal disease
5.Liver impairment or disease
6.Infection
7.Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day
8.Allergy to Levosimendan or previous use of it,
9.Severe arrhythmias needing pace-maker treatment prior to the operation
10.Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation
11.Severe uncorrected hypotension where the initiation of anesthesia is postponed for its correction
12.Re-operation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified