The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation

Study Overview
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Brief Summary
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The purpose of the study is to help determine if either crystalloid solution or colloid solution is more advantageous as a resuscitative fluid in post-operative pediatric cardiac patients.

Detailed Description
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The study is designed to help detect if there is an advantage in giving one type of resuscitative fluid versus another in the setting of post-operative pediatric cardiac patients. The two types of fluid being compared are crystalloid solution (normal saline) and colloid solution (5% albumin). The primary outcome measurement will be how much volume of each type of fluid will be required in order to maintain hemodynamic stability as determined by mean arterial blood pressure within predetermined parameters. Other secondary outcomes will include determinations of lactate clearance, inotropic support requirements, urine output, peripheral and pulmonary edema that occurs post-operatively, and the over all costs for each fluid based on number of required boluses and number of hours on mechanical ventilation.

Official Title
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The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation

Conditions
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Cardiac Diseases

Intervention / Treatment
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* Other: 5% albumin
* Other: crystalloid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Congenital heart defect with two ventricle anatomy and physiology Ages: 0 - 36 months of age Exclusion Criteria: History of bleeding disorder History of renal disorder

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 36 Months

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colloid<br>5% albumin for volume resuscitation | Other: 5% albumin<br>* 5% albumin in 10cc/kg aliquots for postoperative volume resuscitation<br>* Other names: albumin;|
| Placebo Comparator: Crystalloid<br>Saline for volume resuscitation | Other: crystalloid<br>* saline in 10cc/kg aliquots for postoperative volume resuscitation<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure |  | Throughout the post operative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate clearance |  | Throughout the post operative period | 
| inotropic requirements |  | throughout the post operative period | 
| establishment of adequate urine output |  | Throughout the post operative period | 
| post-operative occurrence of edema (peripheral and pulmonary) |  | Througout the post operative period | 
| monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay |  | Throughout the ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative