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

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ClinicalTrials.gov Identifier: NCT00464126
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Cardiac Diseases Other: 5% albumin Other: crystalloid

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  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation
Study Start Date : August 2006
Primary Completion Date : July 2009
Study Completion Date : July 2009
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Colloid
5% albumin for volume resuscitation
Other: 5% albumin
5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
Other Names:
  • colloid
  • albumin
Placebo Comparator: Crystalloid
Saline for volume resuscitation
Other: crystalloid
saline in 10cc/kg aliquots for postoperative volume resuscitation
Other Name: saline


Outcome Measures

Primary Outcome Measures :
  1. maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure [ Time Frame: Throughout the post operative period ]

Secondary Outcome Measures :
  1. lactate clearance [ Time Frame: Throughout the post operative period ]
  2. inotropic requirements [ Time Frame: throughout the post operative period ]
  3. establishment of adequate urine output [ Time Frame: Throughout the post operative period ]
  4. post-operative occurrence of edema (peripheral and pulmonary) [ Time Frame: Througout the post operative period ]
  5. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464126


Locations
United States, Tennessee
The Monroe Carell, Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232-9075
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Mary B Taylor, M.D., MSCI Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
More Information

Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00464126     History of Changes
Other Study ID Numbers: IRB#: 020775
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017

Keywords provided by Vanderbilt University Medical Center:
crystalloid
colloid
pediatric
cardiac
resuscitation
Postoperative

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases