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

• Status: Completed
• Trial end date: 2016-11-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Fabiola Children's University Hospital
• Treatments: Hydroxyethyl Starch Derivatives

Criteria

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