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

Queen Fabiola Children's University Hospital

Status and phase: Completed; Phase 3

Conditions: Cardiac Surgery; Cardiopulmonary Bypass

Treatments: Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution; Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02584868

2011-006034-17

Details and patient eligibility

About

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

Enrollment: 88 patients

Sex: All

Ages: 28 days to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 28 days to 3 years old
• Planned cardiac surgery with cardiopulmonary by-pass
• signed informed consent

Exclusion criteria

• Moribund patients (ASA 5)
• Jehovah Witnesses
• Pre-operative coagulation disorders
• Pre-operative renal insufficiency
• Pre-operative hepatic disorders
• Intra-cranial hemorrhage
• hypernatremia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Volulyte

Experimental group

Description:

Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®)

Treatment:

Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution

Voluven

Active Comparator group

Description:

Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®)

Treatment:

Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride