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

Cardiac Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464126
• Other study ID #: IRB#: 020775
• Status: Completed
• Phase: N/A
• First received: August 18, 2006
• Last updated: March 30, 2017
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: March 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Diseases
• Heart Diseases

Intervention

Other:
• 5% albumin
5% albumin in 10cc/kg aliquots for postoperative volume resuscitation
• crystalloid
saline in 10cc/kg aliquots for postoperative volume resuscitation

Locations

Country	Name	City	State
United States	The Monroe Carell, Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maintenance of hemodynamic stability according to an age specific, predetermined, minimal mean arterial blood pressure		Throughout the post operative period
Secondary	lactate clearance		Throughout the post operative period
Secondary	inotropic requirements		throughout the post operative period
Secondary	establishment of adequate urine output		Throughout the post operative period
Secondary	post-operative occurrence of edema (peripheral and pulmonary)		Througout the post operative period
Secondary	monitoring of cost difference as determined by total number of boluses, number of ventilator hours, and length of ICU stay		Throughout the ICU stay