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

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Cardiac Diseases

Treatments

Other: crystalloid
Other: 5% albumin

Study type

Interventional

Funder types

Other

Identifiers

NCT00464126
IRB#: 020775

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

1 day to 36 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 2 patient groups, including a placebo group

Colloid
Active Comparator group
Description:
5% albumin for volume resuscitation
Treatment:
Other: 5% albumin
Crystalloid
Placebo Comparator group
Description:
Saline for volume resuscitation
Treatment:
Other: crystalloid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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