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Study on the Effect of Surgical Intestinal Manipulation (IMMO)

Primary Purpose

Intestinal Manipulation

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
blood sampling
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Intestinal Manipulation focused on measuring brain-death organ donors, intestinal manipulation, monocytes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • < 18 years of age

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

brain death organ donors

abdominal aortic aneurysm repair

Arm Description

cases - blood sampling

controls - blood sampling

Outcomes

Primary Outcome Measures

subtypes of monocytes
evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection
evaluate effect of intestinal manipulation
evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines

Secondary Outcome Measures

Full Information

First Posted
May 27, 2014
Last Updated
July 10, 2014
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02189512
Brief Title
Study on the Effect of Surgical Intestinal Manipulation
Acronym
IMMO
Official Title
CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Manipulation
Keywords
brain-death organ donors, intestinal manipulation, monocytes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
brain death organ donors
Arm Type
Other
Arm Description
cases - blood sampling
Arm Title
abdominal aortic aneurysm repair
Arm Type
Other
Arm Description
controls - blood sampling
Intervention Type
Other
Intervention Name(s)
blood sampling
Intervention Description
cases - blood sampling controles - blood sampling
Primary Outcome Measure Information:
Title
subtypes of monocytes
Description
evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection
Time Frame
1 day
Title
evaluate effect of intestinal manipulation
Description
evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who are brain death patients who undergo an elective abdominal aortic aneurysm repair Exclusion Criteria: < 18 years of age
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurens Ceulemans, MD
Phone
+32 16 341545
Email
Ceulemans.laurens@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Pirenne, MD,PhD
Organizational Affiliation
Abdominal Transplant Surgery, University Hospitals Leuven, KULeuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Study on the Effect of Surgical Intestinal Manipulation

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