NCT01379638

Brief Summary

The purpose of this study is to determine whether the patients cardiac output measured before cardiopulmonary bypass (CPB), is more sufficient to secure the patients oxygen needs than the estimated cardiac output from Ficks principle, and thereby prevent organ failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
Last Updated

June 23, 2011

Status Verified

December 1, 2008

Enrollment Period

1.1 years

First QC Date

June 22, 2011

Last Update Submit

June 22, 2011

Conditions

Bypass Complications

Keywords

cardiopulmonary bypasscardiac outputflow ratelactate

Study Arms (1)

cardiac output

Adult patients undergoing cardiac surgery with normothermic cardiopulmonary bypass

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients to be admitted to Aalborg Hospital, department of cardiac surgery for scheduled cardiac surgery

You may qualify if:

  • patients admitted for scheduled cardiac surgery during cardiopulmonary bypass
  • Aged 18-90 years
  • LVEF \> 50 %
  • written consent from the patients

You may not qualify if:

  • Former cerebral emboli
  • Former head trauma
  • known stenosis of the arteria carotis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alborg Hospital

Aalborg, Aalborg, 9100, Denmark

Location

Study Officials

  • Bodil Steen Rasmussen, MD, PhD

    Aalborg University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 22, 2011

First Posted

June 23, 2011

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

June 23, 2011

Record last verified: 2008-12

Locations

DK(1)