Measurement of Cardiac Output and Intravascular Volume Status in Children Using COstatus (SH)
2 other identifiers
observational
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 27, 2016
May 1, 2016
2.3 years
May 30, 2012
May 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Comparing CO and other clinical markers in Pediatric ICU
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.
During patients stay in ICU with insitu catheter, expected average 3-4 days
Eligibility Criteria
Pediatric Patients (under 21 years of age) in the ICU
You may qualify if:
- Patients under 21 years
- Presence of compensated or decompensated shock irrespective of etiology
- Presence of an existing peripheral arterial and central venous catheters
You may not qualify if:
- \. Patients allergic to heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shands Children's Hospital, University of Florida
Gainesville, Florida, 32608, United States
Related Publications (1)
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 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
PMID: 18496416BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jai Udassi, MD
Shands Children's Hospital, University of Florida
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 7, 2012
Study Start
January 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 27, 2016
Record last verified: 2016-05