Study on the Effect of Surgical Intestinal Manipulation

Intestinal Manipulation Clinical Trial

— IMMO  

Official title:

CD14/CD16 Activation in Brain-death Organ Donors and Effect of Surgical Intestinal Manipulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189512
• Other study ID #: IMMO-20140206
• Status: Recruiting
• Phase: N/A
• First received: May 27, 2014
• Last updated: July 10, 2014
• Start date: May 2014
• Est. completion date: June 2016

Study information

• Verified date: May 2014
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Laurens Ceulemans, MD
• Phone: +32 16 341545
• Email: Ceulemans.laurens[@]gmail.com
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients who are brain death

• patients who undergo an elective abdominal aortic aneurysm repair

Exclusion Criteria:

• < 18 years of age

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Manipulation

Intervention

Other:
• blood sampling
cases - blood sampling controles - blood sampling

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subtypes of monocytes	evaluate different subtypes of monocytes in brain-death donors by collecting portal and peripheral blood after lapaotomy and before dissection	1 day	No
Primary	evaluate effect of intestinal manipulation	evaluate the effect of intestinal manipulation on the different subtypes of monocytes and pro-/anti-inflammatory cytokines	1 day	No