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

Queen Fabiola Children's University Hospital88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Surgery Cardiopulmonary Bypass

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)

Eligibility

Sex: ALLMin age: 28 DaysMax age: 3 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, Belgium

Outcomes

Primary Outcomes

Calculated Blood Loss at 3rd Post Operative Day (POD)

Time frame: 72H post surgery

Secondary Outcomes

Intraoperative Blood Loss

peri-operative blood losses in ml/kg at the end of surgery

Time frame: End of surgery, an average of 200 minutes

Chest Tube Drainage

Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Time frame: 72H post surgery

Total Blood Loss

Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay

Time frame: 72H post surgery

Exposure to Any Blood Products

Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

Exposure to Red Blood Cell

Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

Red Blood Cell Transfused

Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

Exposure to Fresh Frozen Plasma

Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay)

Time frame: 72H post surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.