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Study on the Effect of Surgical Intestinal Manipulation (IMMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189512
Recruitment Status : Unknown
Verified May 2014 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Brief Summary:
The aim of this study is to study the impact of brain death and surgical small bowel manipulation on the release of different types of monocytes.

Condition or disease Intervention/treatment Phase
Intestinal Manipulation Other: blood sampling Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation
Study Start Date : May 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
brain death organ donors
cases - blood sampling
 Other: blood sampling
cases - blood sampling controles - blood sampling
abdominal aortic aneurysm repair
controls - blood sampling
 Other: blood sampling
cases - blood sampling controles - blood sampling


Outcome Measures
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Primary Outcome Measures :
  1. subtypes of monocytes [ Time Frame: 1 day ]
    evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection

  2. evaluate effect of intestinal manipulation [ Time Frame: 1 day ]
    evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who are brain death
  • patients who undergo an elective abdominal aortic aneurysm repair

Exclusion Criteria:

  • < 18 years of age
Contacts and Locations
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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): NCT02189512


Contacts
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Contact: Laurens Ceulemans, MD +32 16 341545 Ceulemans.laurens@gmail.com

Locations
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Belgium
University Hospitals Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Jacques Pirenne, MD,PhD Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02189512    
Other Study ID Numbers: IMMO-20140206
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: July 14, 2014
Last Verified: May 2014
Keywords provided by Universitaire Ziekenhuizen Leuven:
brain-death organ donors
intestinal manipulation
monocytes
Additional relevant MeSH terms:
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Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
 Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes