NCT00547859

Brief Summary

The purpose of this study is to correlate microcirculatory flow and rectal anaerobe cellular CO2 production in patients after cardiac surgery. The hypothesis is that such a correlation exists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2007

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 26, 2008

Status Verified

November 1, 2008

Enrollment Period

11 months

First QC Date

October 22, 2007

Last Update Submit

November 25, 2008

Conditions

Cardiac Surgery

Keywords

microcirculationcardiac surgerymetabolismcapnometry

Outcome Measures

Primary Outcomes (1)

  • Relation between MFI (by SDF) and capno

    6 months

Secondary Outcomes (1)

  • Relevance of changes in flow and metabolism

    6 months

Eligibility Criteria

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

post cardiac surgery patients in the first two hours of ICU treatment

You may qualify if:

  • cardiac surgery
  • informed consent
  • age \> 18

You may not qualify if:

  • pregnancy
  • off pump procedure
  • rectal fecal contamination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ICU

Leeuwarden, PO Box 888, 8901BR, Netherlands

Location

Related Publications (1)

  • Boerma EC, Mathura KR, van der Voort PH, Spronk PE, Ince C. Quantifying bedside-derived imaging of microcirculatory abnormalities in septic patients: a prospective validation study. Crit Care. 2005;9(6):R601-6. doi: 10.1186/cc3809. Epub 2005 Sep 22.

    PMID: 16280059BACKGROUND

Study Officials

  • E.C. Boerma, MD

    Frisius Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

November 26, 2008

Record last verified: 2008-11

Locations

NL(1)