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Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism

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ClinicalTrials.gov Identifier: NCT00547859
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : November 26, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Cardiac Surgery

Detailed 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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery
Study Start Date : November 2007
Primary Completion Date : October 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Relation between MFI (by SDF) and capno [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Relevance of changes in flow and metabolism [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
post cardiac surgery patients in the first two hours of ICU treatment
Criteria

Inclusion Criteria:

  • cardiac surgery
  • informed consent
  • age > 18

Exclusion Criteria:

  • pregnancy
  • off pump procedure
  • rectal fecal contamination
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547859


Locations
Netherlands
Department of ICU
Leeuwarden, PO box 888, Netherlands, 8901BR
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: E.C. Boerma, MD Medical Centre Leeuwarden
More Information

Publications:
Responsible Party: EC Boerma, Medical Center Leeuwarden
ClinicalTrials.gov Identifier: NCT00547859     History of Changes
Other Study ID Numbers: TPO 503
ABR 19609
First Posted: October 23, 2007    Key Record Dates
Last Update Posted: November 26, 2008
Last Verified: November 2008

Keywords provided by Medical Centre Leeuwarden:
microcirculation
cardiac surgery
metabolism
capnometry