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

NCT00519350 | Completed DMC

• 1 other identifier: 074016
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Inflammatory Response Syndrome; Sepsis

Keywords

SIRS, sepsis and related syndromes

Study Arms (3)

I

Liver surgery

Procedure: Blood collection

II

Colon surgery

Procedure: Blood collection

III

Femur Fracture

Procedure: Blood collection

Interventions

Blood collection PROCEDURE

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

I; II; III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in Maastricht University Hospital area undergoing one of selected types of surgery

You may qualify if:

• \> 18 years
• elective liver / colon / femur surgery

You may not qualify if:

• Acute inflammation
• Chronic Obstructive Respiratory Disease
• Recent history of abdominal pain or diarrhea
• BMI \< 18.5
• Alcohol or Drugs abuses
• Recent intake of antibiotics

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Hospital

Maastricht, Limburg, 6229HX, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Sepsis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jan-Willem Greve, Professor

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 22, 2007
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 24, 2017

Record last verified: 2010-03

Locations

NL (1)