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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00464126
First received: August 18, 2006
Last updated: March 2, 2011
Last verified: March 2011
  Purpose

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 Intervention
Cardiac Diseases
Other: 5% albumin
Other: crystalloid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of Colloid Versus Crystalloid in Post-operative Pediatric Cardiac Patients for Fluid Resuscitation

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure [ Time Frame: Throughout the post operative period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • lactate clearance [ Time Frame: Throughout the post operative period ] [ Designated as safety issue: Yes ]
  • inotropic requirements [ Time Frame: throughout the post operative period ] [ Designated as safety issue: Yes ]
  • establishment of adequate urine output [ Time Frame: Throughout the post operative period ] [ Designated as safety issue: Yes ]
  • post-operative occurrence of edema (peripheral and pulmonary) [ Time Frame: Througout the post operative period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2006
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 36 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Mary B Taylor, M.D., MSCI Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care
  More Information

No publications provided

Responsible Party: Mary B. Taylor, MD, MSCI, FAAP, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00464126     History of Changes
Other Study ID Numbers: IRB#: 020775
Study First Received: August 18, 2006
Last Updated: March 2, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014