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

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

Conditions
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Cardiac Surgery, Cardiopulmonary Bypass

Intervention / Treatment
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* Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
* Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volulyte<br>Investigational drug: HES 130/0.4 (6%) in an isotonic electrolyte solution (brand name=Volulyte®) | Drug: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution<br>* Peri-operative fluid replacement therapy (max 40ml/kg/day)<br>* Other names: Volulyte;|
| Active Comparator: Voluven<br>Control drug: HES 130/0.4 (6%) in sodium chloride 0.9% (brand name=Voluven®) | Drug: Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride<br>* Peri-operative fluid replacement therapy (max 40ml/kg/day)<br>* Other names: Voluven;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculated Blood Loss at 3rd Post Operative Day (POD) |  | 72H post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood Loss | peri-operative blood losses in ml/kg at the end of surgery | End of surgery, an average of 200 minutes | 
| Chest Tube Drainage | Total chest tube drainage during Pediatric Intensive Care Unit (PICU) stay | 72H post surgery | 
| Total Blood Loss | Total blood loss Intraoperative + chest tube drainage during Pediatric Intensive Care Unit (PICU) stay | 72H post surgery | 
| Exposure to Any Blood Products | Transfusion of any blood product (intraoperative + during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Exposure to Red Blood Cell | Transfusion of Red Blood Cell (intraoperative + during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Red Blood Cell Transfused | Red Blood Cell transfused in transfused patients in ml/kg (intraoperative + during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Exposure to Fresh Frozen Plasma | Transfusion of Fresh Frozen Plasma (intraoperative and during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Fresh Frozen Plasma Transfused | Fresh Frozen Plasma transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Exposure to Platelets | Transfusion of platelets (intraoperative and during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Platelet Transfused | Platelet transfusion in ml/kg (intraoperative and during Pediatric Intensive Care Unit stay) | 72H post surgery | 
| Creatinine |  | At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery) | 
| C-Reactive Protein (CRP) |  | At admission to the pediatric intensive care unit (Hour 0 Day 0 after surgery) | 
| PTT |  | End of surgery, an average of 200 minutes | 
| APTT |  | End of surgery, an average of 200 minutes | 
| INR |  | End of surgery, an average of 200 minutes | 
| Fibrinogen |  | End of surgery, an average of 200 minutes | 
| Clotting Time in Seconds | Clotting time on EXTEM ROTEM® | End of surgery, an average of 200 minutes | 
| Maximal Cloth Firmness | Maximal cloth firmness on EXTEM ROTEM® | End of surgery, an average of 200 minutes | 
| Creatinine |  | Post-operative Day 1 | 
| CRP |  | Post-operative Day 1 | 
| PTT |  | Post-operative Day 1 | 
| APTT |  | Post-operative Day 1 | 
| INR |  | Post-operative Day 1 | 
| Fibrinogen |  | Post-operative Day 1 | 
| Creatinine |  | Post-operative Day 2 | 
| CRP |  | Post-operative Day 2 | 
| PTT |  | Post-operative Day 2 | 
| APTT |  | Post-operative Day 2 | 
| INR |  | Post-operative Day 2 | 
| Fibrinogen |  | Post-operative Day 2 | 
| Creatinine |  | Post-operative Day 3 | 
| CRP |  | Post-operative Day 3 |