Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism
This study has been completed.
Sponsor:
Medical Centre Leeuwarden
Information provided by:
Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT00547859
First received: October 22, 2007
Last updated: November 25, 2008
Last verified: November 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 22, 2007 | ||||
| Last Updated Date | November 25, 2008 | ||||
| Start Date ICMJE | November 2007 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Relation between MFI (by SDF) and capno [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
relation between MFI (by SDF) and capno [ Time Frame: 6 months ] | ||||
| Change History | Complete list of historical versions of study NCT00547859 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Relevance of changes in flow and metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
relevance of changes in flow and metabolism [ Time Frame: 6 months ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Relationship Between Microcirculatory Flow Alterations and Tissue Metabolism | ||||
| Official Title ICMJE | Correlation Between Microcirculatory Flow and Rectal Anaerobe Cellular CO2 Production in Patients After Cardiac Surgery | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | post cardiac surgery patients in the first two hours of ICU treatment |
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| Condition ICMJE | Cardiac Surgery | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | October 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00547859 | ||||
| Other Study ID Numbers ICMJE | TPO 503, ABR 19609 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | EC Boerma, Medical Center Leeuwarden | ||||
| Study Sponsor ICMJE | Medical Centre Leeuwarden | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Medical Centre Leeuwarden | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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