CompletedPhase 2

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

Finland, Sweden72 participantsStarted 2014-10-15

Plain-language 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).

Who can participate

Age range1 Month – 12 Months

SexALL

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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).

What they're measuring

S-creatinine

Timeframe: One day after cardiac surgery

Trial details

NCT IDNCT02232399

SponsorGöteborg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-25

Results submitted2022-05-09

View on ClinicalTrials.gov More Congenital Heart Defects trials