The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 1 Day to 36 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Colloid
5% albumin for volume resuscitation
Intervention: 5% albumin (Other)
Crystalloid
Saline for volume resuscitation
Intervention: crystalloid (Other)
Outcomes
Primary Outcomes
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Time Frame: Throughout the post operative period
Secondary Outcomes
- 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)