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Clinical Trials/NCT01613859
NCT01613859
Completed
Not Applicable

Measurement of Cardiac Output and Intravascular Volume Status in Critically Ill Children Using an Ultrasound Dilution Method (COstatus)

Transonic Systems Inc.1 site in 1 country9 target enrollmentJanuary 2012
ConditionsIntensive Care

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care
Sponsor
Transonic Systems Inc.
Enrollment
9
Locations
1
Primary Endpoint
Comparing CO and other clinical markers in Pediatric ICU
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
May 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patients allergic to heparin

Outcomes

Primary Outcomes

Comparing CO and other clinical markers in Pediatric ICU

Time Frame: During patients stay in ICU with insitu catheter, expected average 3-4 days

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.

Study Sites (1)

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