Status:
COMPLETED
Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
Lead Sponsor:
Göteborg University
Collaborating Sponsors:
Helsinki University Central Hospital
Conditions:
Congenital Heart Defects
Eligibility:
All Genders
1-12 years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess the ability of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs).
Detailed Description
Young children, between the age of 1 to 12 months, with congenital heart disease in need of elective heart surgery will be included in this study. The trial will contain two study groups, 35 patients...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Female and male children between 1 and 12 months of age
- Non-restrictive VSD (corrective surgery)
- Complete AVSD (biventricular repair)
- Tetralogy of Fallot
Exclusion
- Unbalanced AtrioVentricular Septal Defect or AVSD with cyanosis
- Age less than one month and more than one year
- Acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
- Mild, moderate, or severe kidney dysfunction and known anatomical anomalies of kidneys
- Liver impairment or disease
- Ongoing infection
- Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day. Contrast agents whithin 24 hours before operation.
- Use of inhibitors of membrane transport proteins (cimetidine, cetirizine, trimethoprim, probenecid, rifampin and gemfibrosil).
- Allergy to Levosimendan or substance included in the preparation or previous use of Levosimendan.
- Severe arrhythmias needing pace-maker treatment prior to the operation
- Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation.
- Preoperative need for mechanical ventilation and/or inotropic agents.
- Re-operation (open heart surgery). Earlier surgical closure of the arterial duct does not count as an exclusion criteria.
- Prematurity: Gestational age \< 30 weeks, irrespective of postpartum age. Gestational age 30-34 weeks if patient is included at postpartum age under 3 months.
Key Trial Info
Start Date :
October 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 25 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02232399
Start Date
October 15 2014
End Date
April 25 2017
Last Update
March 26 2024
Active Locations (2)
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1
Children´s Hospital, Helsinki University Central Hospital
Helsinki, Finland, FIN-00029 HYKS
2
Queen Silvia Children´s Hospital
Gothenburg, Västra Götaland County, Sweden, 416 85