Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00853437
First received: February 27, 2009
Last updated: May 25, 2016
Last verified: May 2016
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure blood volumes to compare effects of volume infusion and furosemide. [ Time Frame: 5-8 minutes minimum ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 16 Years   (Child)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 27, 2009
Last Updated: May 25, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 23, 2016