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Clinical Trials/NCT00464126
NCT00464126
Completed
Not Applicable

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

Vanderbilt University Medical Center1 site in 1 country32 target enrollmentAugust 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Diseases
Sponsor
Vanderbilt University Medical Center
Enrollment
32
Locations
1
Primary Endpoint
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
July 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

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)

Study Sites (1)

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