Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage
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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 |
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| 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 |
Patients in Maastricht University Hospital area undergoing one of selected types of surgery
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| Netherlands | |
| Maastricht University Hospital | |
| Maastricht, Limburg, Netherlands, 6229HX | |
| 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 Sepsis Systemic Inflammatory Response Syndrome |
Pathologic Processes Infection Shock |
ClinicalTrials.gov processed this record on May 22, 2013