NCT01103895

Brief Summary

Cardiac output, the amount of blood pumped by the heart in one minute, will be measured in adults undergoing surgery involving cardiopulmonary bypass. Cardiac output will be measured before and after cardiopulmonary bypass using a device that employs ultrasound dilution technology. The ultrasound dilution cardiac output measurements will be validated or compared with cardiac output measurements made using thermodilution, which is the current "gold standard."

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

July 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

April 13, 2010

Last Update Submit

May 25, 2016

Conditions

Cardiac Output

Keywords

cardiac outputcardiopulmonary bypassultrasound dilution

Outcome Measures

Primary Outcomes (1)

  • Cardiac output after cardiopulmonary bypass

    Cardiac output will be measured using an ultrasound dilution technique and compared with cardiac output measured using thermodilution after the completion of surgical procedures involving cardiopulmonary bypass.

    Less than 10 minutes

Secondary Outcomes (1)

  • Cardiac output before cardiopulmonary bypass

    Less than 10 minutes

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Measurement of cardiac output before and after cardiopulmonary bypass in adult patients.

You may qualify if:

  • Patients aged \> 21 years
  • Patients undergoing surgery involving cardiopulmonary bypass
  • Patients instrumented with a thermodilution catheter

You may not qualify if:

  • Patients aged \< 21 years
  • Patients undergoing surgery "off pump" (not involving cardiopulmonary bypass)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arnot Ogden Medical Center

Elmira, New York, 14905, United States

Location

Study Officials

  • Nikolai Krivitski, PhD, DSc

    Transonic Systems Inc.

    PRINCIPAL INVESTIGATOR

  • Edward P Nast, MD

    Arnot Ogden Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 15, 2010

Study Start

July 1, 2007

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

May 27, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)