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

This study is currently recruiting participants.
Verified May 2012 by Transonic Systems Inc.
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 30, 2012
Last verified: May 2012
History of Changes

February 27, 2009
May 30, 2012
January 2009
May 2013   (final data collection date for primary outcome measure)
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 ]
Compare CO measured by the new method with clinician's estimate and implied CO from measurement of arteriovenous oxygen content difference. [ Time Frame: 1-3 years (2009-2011) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00853437 on ClinicalTrials.gov Archive Site
Measure blood volumes to compare effects of volume infusion and furosemide. [ Time Frame: 5-8 minutes minimum ] [ Designated as safety issue: No ]
Measure blood volumes to compare effects of volume infusion and furosemide. [ Time Frame: 1-3 years (2009-2011) ] [ Designated as safety issue: No ]
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Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Pediatric patients (up to 16 years of age ) in the ICU with in situ central venous and arterial catheters.
Cardiac Output
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Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 May 19; [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
up to 16 Years
No
Contact: Karen Powers, MD 585-275-8138 Karen_Powers@URMC.Rochester.edu
United States
 
NCT00853437
TSI-G-COSTATUS-2A-H, 2R44HL061994-04A2
No
Transonic Systems Inc.
Transonic Systems Inc.
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Karen Powers, MD Golisano Children's Hospital
Transonic Systems Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP