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

March 30, 2017 updated by: Vanderbilt University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-9075
        • The Monroe Carell, Jr. Children's Hospital at Vanderbilt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure
Time Frame: Throughout the post operative period
Throughout the post operative period

Secondary Outcome Measures

Outcome Measure
Time Frame
lactate clearance
Time Frame: Throughout the post operative period
Throughout the post operative period
inotropic requirements
Time Frame: throughout the post operative period
throughout the post operative period
establishment of adequate urine output
Time Frame: Throughout the post operative period
Throughout the post operative period
post-operative occurrence of edema (peripheral and pulmonary)
Time Frame: Througout the post operative period
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
Time Frame: Throughout the ICU stay
Throughout the ICU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Mary B Taylor, M.D., MSCI, Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#: 020775

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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