NCT00464126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

August 18, 2006

Last Update Submit

March 30, 2017

Conditions

Cardiac Diseases

Keywords

crystalloidcolloidpediatriccardiacresuscitationPostoperative

Outcome Measures

Primary Outcomes (1)

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

    Throughout the post operative period

Secondary Outcomes (5)

  • 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

Study Arms (2)

Colloid

ACTIVE COMPARATOR

5% albumin for volume resuscitation

Other: 5% albumin

Crystalloid

PLACEBO COMPARATOR

Saline for volume resuscitation

Other: crystalloid

Interventions

5% albuminOTHER

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

Also known as: colloid, albumin
Colloid
crystalloidOTHER

saline in 10cc/kg aliquots for postoperative volume resuscitation

Also known as: saline
Crystalloid

Eligibility Criteria

Age1 Day - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • History of bleeding disorder
  • History of renal disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nashville, Tennessee, 37232-9075, United States

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

AlbuminsColloidsCrystalloid SolutionsSodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsComplex MixturesDosage FormsPharmaceutical PreparationsIsotonic SolutionsSolutionsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mary B Taylor, M.D., MSCI

    Vanderbilt University Medical Center Department of Pediatrics Division of Critical Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2006

First Posted

April 20, 2007

Study Start

August 1, 2006

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

US(1)