Back to resultsThe Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Primary Purpose
Cardiac Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5% albumin
crystalloid
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Diseases focused on measuring crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative
Eligibility Criteria
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
Sites / Locations
- The Monroe Carell, Jr. Children's Hospital at Vanderbilt
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Colloid
Crystalloid
Arm Description
5% albumin for volume resuscitation
Saline for volume resuscitation
Outcomes
Primary Outcome Measures
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Secondary Outcome Measures
lactate clearance
inotropic requirements
establishment of adequate urine output
post-operative occurrence of edema (peripheral and pulmonary)
monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay
Full Information
NCT ID
NCT00464126
First Posted
August 18, 2006
Last Updated
March 30, 2017
Sponsor
Vanderbilt University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00464126
Brief Title
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Official Title
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Diseases
Keywords
crystalloid, colloid, pediatric, cardiac, resuscitation, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colloid
Arm Type
Active Comparator
Arm Description
5% albumin for volume resuscitation
Arm Title
Crystalloid
Arm Type
Placebo Comparator
Arm Description
Saline for volume resuscitation
Intervention Type
Other
Intervention Name(s)
5% albumin
Other Intervention Name(s)
colloid, albumin
Intervention Description
5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
Intervention Type
Other
Intervention Name(s)
crystalloid
Other Intervention Name(s)
saline
Intervention Description
saline in 10cc/kg aliquots for postoperative volume resuscitation
Primary Outcome Measure Information:
Title
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Time Frame
Throughout the post operative period
Secondary Outcome Measure Information:
Title
lactate clearance
Time Frame
Throughout the post operative period
Title
inotropic requirements
Time Frame
throughout the post operative period
Title
establishment of adequate urine output
Time Frame
Throughout the post operative period
Title
post-operative occurrence of edema (peripheral and pulmonary)
Time Frame
Througout the post operative period
Title
monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay
Time Frame
Throughout the ICU stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary B Taylor, M.D., MSCI
Organizational Affiliation
Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Monroe Carell, Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-9075
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
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