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

Not Applicable

Completed

• Conditions: Cardiac Diseases
• Interventions: Other: 5% albumin; Other: crystalloid

• Registration Number: NCT00464126
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-18
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Congenital heart defect with two ventricle anatomy and physiology
• Ages: 0 - 36 months of age

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Exclusion Criteria

• History of bleeding disorder
• History of renal disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colloid	5% albumin	5% albumin for volume resuscitation
Crystalloid	crystalloid	Saline for volume resuscitation

Primary Outcome Measures

Name	Time	Method
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure	Throughout the post operative period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Monroe Carell, Jr. Children's Hospital at Vanderbilt; 🇺🇸 Nashville, Tennessee, United States