NCT00851474

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

2.2 years

First QC Date

February 25, 2009

Last Update Submit

May 25, 2016

Conditions

Cardiac Output

Keywords

COstatus(R)Ultrasound DilutionCardiac OutputBlood VolumesComparison of COstatus(R) cardiac output with other methods

Outcome Measures

Primary Outcomes (1)

  • Compare cardiac output measured by COstatus(R) with other methods such as PA Thermodilution

    5-8 minutes minimum

Secondary Outcomes (1)

  • Measure blood volumes

    5-8 minutes minimum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (older than 18 years of age) in the Intensive Care Unit with arterial and central venous catheters in place.

You may qualify if:

  • Adult patients (older than 18 years of age)
  • Should have both arterial and central venous catheters already in place

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

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

  • Lawrence Diebel, MD

    Wayne State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2009

First Posted

February 26, 2009

Study Start

March 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 27, 2016

Record last verified: 2016-05

Locations

US(1)