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Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid

NCT02584868 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2020-11-09

Study results available
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Summary

This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.

Conditions

  • Cardiac Surgery
  • Cardiopulmonary Bypass

Interventions

DRUG

Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

Peri-operative fluid replacement therapy (max 40ml/kg/day)

DRUG

Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

Peri-operative fluid replacement therapy (max 40ml/kg/day)

Sponsors & Collaborators

  • Queen Fabiola Children's University Hospital

    lead OTHER

Principal Investigators

  • Philippe Van der Linden, MDPhD · HUDERF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-15
Primary Completion
2016-11-21
Completion
2016-11-21

Countries

  • Belgium

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 NCT02584868 on ClinicalTrials.gov