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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519350
First Posted: August 22, 2007
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Systemic Inflammatory Response Syndrome Sepsis Procedure: Blood collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Biospecimen Retention:   Samples Without DNA
plasma

Enrollment: 24
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
I
Liver surgery
Procedure: Blood collection
In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation
II
Colon surgery
Procedure: Blood collection
In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation
III
Femur Fracture
Procedure: Blood collection
In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in Maastricht University Hospital area undergoing one of selected types of surgery
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519350


Locations
Netherlands
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6229HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Jan-Willem Greve, Professor Maastricht University Medical Center
  More Information

Responsible Party: Jan-Willem Greve, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00519350     History of Changes
Other Study ID Numbers: 074016
First Submitted: August 21, 2007
First Posted: August 22, 2007
Last Update Posted: February 24, 2017
Last Verified: March 2010

Keywords provided by Maastricht University Medical Center:
SIRS, sepsis and related syndromes

Additional relevant MeSH terms:
Inflammation
Sepsis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Infection
Shock