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NCT00519350 Clinical Trial

Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage

Sepsis Clinical Trial

Official title:
Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00519350
Other study ID # 074016
Secondary ID
Status Completed
Phase N/A
First received August 21, 2007
Last updated February 22, 2017
Start date August 2007
Est. completion date June 2009

Study information
Verified date March 2010
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently, the researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding administered before shock attenuates inflammation and reduces intestinal and hepatic damage. In the mechanism that underlies this protective effect, the release of cholecystokinin in gut wall and activation of efferent vagus bundles are crucial events. Before investigating the effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ damage need to be selected. In this study, blood will be collected in patients undergoing different types of operations. Consequently several markers for inflammation and organ damage will be determined. Hence, suitable parameters for a future high-fat intervention study will be selected.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- > 18 years

- elective liver / colon / femur surgery

Exclusion Criteria:

- Acute inflammation

- Chronic Obstructive Respiratory Disease

- Recent history of abdominal pain or diarrhea

- BMI < 18.5

- Alcohol or Drugs abuses

- Recent intake of antibiotics

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood collection
In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation

Locations
Country Name City State
Netherlands Maastricht University Hospital Maastricht Limburg

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

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