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

NCT ID: NCT00519350

Last Updated: 2017-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Inflammatory Response Syndrome Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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I

Liver surgery

Blood collection

Intervention Type PROCEDURE

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

II

Colon surgery

Blood collection

Intervention Type PROCEDURE

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

III

Femur Fracture

Blood collection

Intervention Type PROCEDURE

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

Interventions

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Blood collection

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Maastricht

Principal Investigators

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Jan-Willem Greve, Professor

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Maastricht University Hospital

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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074016

Identifier Type: -

Identifier Source: org_study_id

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