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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00519350
First received: August 21, 2007
Last updated: March 30, 2010
Last verified: March 2010
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jan-Willem Greve, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00519350     History of Changes
Other Study ID Numbers: 074016
Study First Received: August 21, 2007
Last Updated: March 30, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on September 18, 2014