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

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ClinicalTrials.gov Identifier: NCT00853437
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : May 27, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.

Brief Summary:
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 or disease
Cardiac Output

Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
Study Start Date : January 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011



Primary Outcome Measures :
  1. 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 :
  1. Measure blood volumes to compare effects of volume infusion and furosemide. [ Time Frame: 5-8 minutes minimum ]


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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.

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

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 Posted: March 2, 2009    Key Record Dates
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