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

Phase 2 Completed 72 enrolled Göteborg University Helsinki University Central Hospital · collab

RandomizedParallel-groupDouble-blindPrevention

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).

Timeline

Start: 2014-10-15
Primary completion: 2017-04-25
Completion: 2017-04-25

Outcome

Missed primary endpoint

registry analysis (other test); Milrinone vs Levosimendan; p = 0.45; Mixed Models Analysis NCT02232399 ↗

Publications

Thorlacius EM, Vistnes M, Ojala T, Keski-Nisula J, Molin M, Romlin BS, Synnergren M, Ricksten SE, Wahlander H, Castellheim A. Levosimendan Versus Milrinone and Release of Myocardial Biomarkers After Pediatric Cardiac Surgery: Post Hoc Analysis of Clinical Trial Data. Pediatr Crit Care Med. 2021 Jul 1;22(7):e402-e409. doi: 10.1097/PCC.0000000000002712.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levosimendan	Other / unclassified	0.1 ug/kg	—
Comparator	Milrinone	Small molecule	0.4 ug/kg	—