Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
NCT ID: NCT02584868
Last Updated: 2020-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2013-02-15
2016-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Volulyte
Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)
Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Voluven
Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)
Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Interventions
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Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Peri-operative fluid replacement therapy (max 40ml/kg/day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Planned cardiac surgery with cardiopulmonary by-pass
* signed informed consent
Exclusion Criteria
* Jehovah Witnesses
* Pre-operative coagulation disorders
* Pre-operative renal insufficiency
* Pre-operative hepatic disorders
* Intra-cranial hemorrhage
* hypernatremia
28 Days
3 Years
ALL
No
Sponsors
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Queen Fabiola Children's University Hospital
OTHER
Responsible Party
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Principal Investigators
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Philippe Van der Linden, MDPhD
Role: PRINCIPAL_INVESTIGATOR
HUDERF
Locations
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Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, , Belgium
Countries
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References
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Willems A, De Groote F, Schmartz D, Fils JF, Van der Linden P. Does a balanced colloid decrease perioperative blood loss in paediatric cardiac surgery: A double-blinded randomized controlled trial? Eur J Anaesthesiol. 2021 Sep 1;38(9):923-931. doi: 10.1097/EJA.0000000000001526.
Other Identifiers
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2011-006034-17
Identifier Type: -
Identifier Source: org_study_id