Clinical Trials Directory

Trials / Completed

CompletedNCT00464126

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
1 Day – 36 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHER5% albumin5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
OTHERcrystalloidsaline in 10cc/kg aliquots for postoperative volume resuscitation

Timeline

Start date
2006-08-01
Primary completion
2009-07-01
Completion
2009-07-01
First posted
2007-04-20
Last updated
2017-04-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00464126. Inclusion in this directory is not an endorsement.