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

NCT02232399 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-26

Study results available
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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).

Conditions

  • Congenital Heart Defects

Interventions

DRUG

Levosimendan

The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.

DRUG

Milrinone

The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Albert Castellheim, MD, PhD · Queen Silvia Children´s Hospital, Department of anesthesia and intensive care

  • Håkan Wåhlander, MD, PhD · Queen Silvia Children´s Hospital, Department of pediatric cardiology

  • Birgitta Romlin, MD, PhD · Queen Silvia Children´s Hospital, Department of anesthesiology and intensive care

  • Elin Thorlacius, MD · Queen Silvia Children´s Hospital, Department of anesthesiology and intensive care

  • Sven-Erik Ricksten, MD, PhD · Sahlgrenska University Hospital, Department of anesthesiology and intensive care

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Finland
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02232399 on ClinicalTrials.gov