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Phase 2 N=72 Randomized Double-blind Prevention

Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?

Congenital Heart Defects

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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