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Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients (GCH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853437
First Posted: March 2, 2009
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
  Purpose
The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.

Condition
Cardiac Output

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference. [ Time Frame: 5-8 minutes minimum ]

Secondary Outcome Measures:
  • Measure blood volumes to compare effects of volume infusion and furosemide. [ Time Frame: 5-8 minutes minimum ]

Enrollment: 7
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.
Criteria

Inclusion Criteria:

  • Patients with in situ central venous and arterial catheters
  • Ability to draw blood from arterial and central venous catheters
  • Presence of parent or guardian to provide consent

Exclusion Criteria:

  • Patients over 16 years of age.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853437


Locations
United States, New York
Golisano Children's Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Karen Powers, MD Golisano Children's Hospital
  More Information

Publications:
Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00853437     History of Changes
Other Study ID Numbers: TSI-G-COSTATUS-2A-H
2R44HL061994-04A2 ( U.S. NIH Grant/Contract )
First Submitted: February 27, 2009
First Posted: March 2, 2009
Last Update Posted: May 27, 2016
Last Verified: May 2016

Keywords provided by Transonic Systems Inc.:
Comparison of CO by new method to clinician's estimate and implied CO from the measurement of arteriovenous oxygen content difference.

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes