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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00851474
Other study ID # TSI-C-COSTATUS-7A-H
Secondary ID 2R44HL061994-04A
Status Withdrawn
Phase N/A
First received February 25, 2009
Last updated May 25, 2016
Start date March 2009
Est. completion date May 2011

Study information

Verified date May 2016
Source Transonic Systems Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

Cardiac Output (amount of blood pumped by the heart in one minute) will be measured using the new COstatus(R) system and these values will be compared with cardiac output values measured by other methods such as thermodilution. Blood volumes measured by the COstatus(R) system will also be recorded.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients (older than 18 years of age)

- Should have both arterial and central venous catheters already in place

Exclusion Criteria:

- Patients who do not have either the arterial or central venous catheters.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wayne State University Detroit Michigan

Sponsors (2)

Lead Sponsor Collaborator
Transonic Systems Inc. National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Compare cardiac output measured by COstatus(R) with other methods such as PA Thermodilution 5-8 minutes minimum No
Secondary Measure blood volumes 5-8 minutes minimum No
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