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Completed

NCT Number: NCT00464126

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

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.

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Key information

Conditions

Cardiac Diseases Cardiovascular Diseases Heart Diseases

Age range

1 day–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Monroe Carell, Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232-9075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% albumin

Other

5% albumin in 10cc/kg aliquots for postoperative volume resuscitation

Other names: colloid, albumin

crystalloid

Other

saline in 10cc/kg aliquots for postoperative volume resuscitation

Other names: saline

Primary outcomes

  1. maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure

    Time frame: Throughout the post operative period

Secondary outcomes

  1. lactate clearance

    Time frame: Throughout the post operative period

  2. inotropic requirements

    Time frame: throughout the post operative period

  3. establishment of adequate urine output

    Time frame: Throughout the post operative period

  4. post-operative occurrence of edema (peripheral and pulmonary)

    Time frame: Througout the post operative period

  5. 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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2007
Registry last updated
Apr 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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