NCT01252394

Brief Summary

The study aims to investigate the correspondence between changes in central venous oxygen saturation (ScO2) and in cardiac output during hemodialysis. In 12 hemodialysis patients with an A-V fistula, a thoracic bioimpedance cardiograph will be validated for cardiac output measurements during ongoing hemodialysis. Provided this validation is satisfactory, impedance cardiography cardiac output and ScO2 will be measured at intervals during hemodialysis in 25 hemodialysis patients with a central vascular access. Absolute values and trends will be compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 3, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

December 2, 2010

Last Update Submit

December 2, 2010

Conditions

Hemodialysis

Study Arms (1)

Hemodialysis patients

Eligibility Criteria

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

Hemodialysis patients

You may qualify if:

  • Ambulatory hemodialysis patients in the Copenhagen University Hospital department of Nephrology.

You may not qualify if:

  • Age below 18 years. Failure to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital

Copenhagen E, 2100, Denmark

RECRUITING

Related Publications (1)

  • Cordtz J, Olde B, Solem K, Ladefoged SD. Central venous oxygen saturation and thoracic admittance during dialysis: new approaches to hemodynamic monitoring. Hemodial Int. 2008 Jul;12(3):369-77. doi: 10.1111/j.1542-4758.2008.00283.x.

    PMID: 18638095BACKGROUND

Study Officials

  • Soeren D Ladefoged, MD

    Dep. of Nephrology, Copenhagen University Hospital.

    STUDY DIRECTOR

Central Study Contacts

Joakim Cordtz, MD

CONTACT

+45 60 85 93 96drcordtz@yahoo.dk

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 3, 2010

Record last verified: 2010-10

Locations

DK(1)