Cardiac Diseases
Conditions
Keywords
crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative
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.
Interventions
OTHER5% albumin
5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
OTHERcrystalloid
saline in 10cc/kg aliquots for postoperative volume resuscitation
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Days to 36 Months
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure | Throughout the post operative period |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed