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

Completed

• Conditions: Intensive Care

• Registration Number: NCT01613859
• Lead Sponsor: Transonic Systems Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-30
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparing CO and other clinical markers in Pediatric ICU	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.

Trial Locations

Locations (1)

Shands Children's Hospital, University of Florida; 🇺🇸 Gainesville, Florida, United States