Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Transonic Systems Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT01613859
First received: May 30, 2012
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

Assessment and monitoring of cardiac function in the pediatric intensive care unit (PICU) is an integral part of hemodynamic monitoring of critically ill patients whether it is done directly or indirectly. Measurement of cardiac output (CO) can specifically guide therapies to support the cardiovascular system in critically ill children with multi organ dysfunction. Because of the side effects involved in measuring cardiac output directly, intensive monitoring of patients is currently limited to an integrated assessment of tissue perfusion, oxygen delivery and cellular health both at regional and global levels. Currently available methods of measuring CO have their limitations and complications, and are not used routinely for bedside monitoring. Therefore, the investigators propose to use a newly developed method, termed COstatus for the monitoring of CO in patients admitted to PICU.


Condition
Intensive Care

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Comparing CO and other clinical markers in Pediatric ICU [ Time Frame: During patients stay in ICU with insitu catheter, expected average 3-4 days ] [ Designated as safety issue: No ]
    The objective of this study is to see if the CO measurements obtained with COstatus show a linear correlation with all other indirect and invasive methods currently used to measure CO (within acceptable range) and with the CO measured by thermodilution in the cardiac catheterization lab.


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric Patients (under 21 years of age) in the ICU

Criteria

Inclusion Criteria:

  1. Patients under 21 years
  2. Presence of compensated or decompensated shock irrespective of etiology
  3. Presence of an existing peripheral arterial and central venous catheters

Exclusion Criteria:

1. Patients allergic to heparin

  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: NCT01613859

Contacts
Contact: Jai Udassi, MD udassjp@peds.ufl.edu

Locations
United States, Florida
Shands Children's Hospital, University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Jai Udassi, MD       udassjp@peds.ufl.edu   
Principal Investigator: Jai Udassi, MD         
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Jai Udassi, MD Shands Children's Hospital, University of Florida
  More Information

Publications:
Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT01613859     History of Changes
Other Study ID Numbers: TSI-G-COstatus-12A-H, R44HL061994
Study First Received: May 30, 2012
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

ClinicalTrials.gov processed this record on August 21, 2014