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NCT00547859 Clinical Trial

Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism

Cardiac Surgery Clinical Trial

Official title:
Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00547859
Other study ID # TPO 503
Secondary ID ABR 19609
Status Completed
Phase N/A
First received October 22, 2007
Last updated November 25, 2008
Start date November 2007
Est. completion date November 2008

Study information
Verified date November 2008
Source Medical Centre Leeuwarden
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Observational

Clinical Trial 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.

Description:

Sidestream Darkfield imaging is used to determine rectal microcirculatory flow in patients after postoperative cardiac surgery. At the same time PCO2 gap is established by monitoring rectal CO2 (tonometry) and arterial CO2 After initial enrollment and first analysis we also includes a control group with equal inclusion criteria for sublingual SDF imaging.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- cardiac surgery

- informed consent

- age > 18

Exclusion Criteria:

- pregnancy

- off pump procedure

- rectal fecal contamination

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Department of ICU Leeuwarden PO box 888

Sponsors (1)
Lead Sponsor Collaborator
Medical Centre Leeuwarden

Country where clinical trial is conducted

Netherlands, 

References & 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. Epub 2005 Sep 22. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Relation between MFI (by SDF) and capno 6 months No
Secondary Relevance of changes in flow and metabolism 6 months No
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