Phase 2
N=72
Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?
Congenital Heart Defects
Bottom Line
View on ClinicalTrials.gov: NCT02232399 ↗Enrolled (actual)
72
Serious AEs
21.4%
Results posted
Mar 2024
Primary outcome: Primary: S-creatinine — 23.9; 25.9; 33.7; 34.2 μmol/L — p=0.45
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Levosimendan (Drug); Milrinone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Göteborg University
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY S-creatinine |
23.9; 25.9; 33.7; 34.2 | 0.45 |
| SECONDARY Acute Kidney Injury (AKI) |
15; 15 | 0.70 |
| SECONDARY 30 Days Mortality |
0; 0 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02232399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.