At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution +1 moredrug
Likely dose
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution 40mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
In Brief
A Phase 3 clinical trial evaluating Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution and Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride for Cardiac Surgery and Cardiopulmonary Bypass. Completed, enrolled 88 participants across 1 site.
Detailed Summary
This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during elective open-heart surgery in pediatric patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery, Cardiopulmonary Bypass
CountriesBelgium
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
First PostedOct 2015
Primary CompletionNov 2016
TodayJul 2026
First PostedOct 23, 2015
Enrollment StartFeb 15, 2013
Primary CompletionNov 21, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 10.7 years ago
Interventions
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solutiondrug
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Hydroxyethyl starch 130/0.4 in 0.9% sodium chloridedrug
Peri-operative fluid replacement therapy (max 40ml/kg/day)