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Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism

This study has been completed.
Sponsor:
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT00547859
First received: October 22, 2007
Last updated: November 25, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery

Resource links provided by NLM:

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

Further study details as provided by Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Relation between MFI (by SDF) and capno [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relevance of changes in flow and metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: October 22, 2007
Last Updated: November 25, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on May 21, 2013