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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01613859
Enrollment
9
Registered
2012-06-07
Start date
2012-01-31
Completion date
2014-05-31
Last updated
2016-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intensive Care

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.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Transonic Systems Inc.
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing CO and other clinical markers in Pediatric ICUDuring patients stay in ICU with insitu catheter, expected average 3-4 daysThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026