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Immunoregulatory Dysfunction in Trauma Patients: Role of Obesity (ObesityRole)

This study has been terminated.
(Enrollment process not efficient)
Sponsor:
Information provided by (Responsible Party):
University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT00833287
First received: January 30, 2009
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

Patient who have major traumatic injury are at risk to develop postoperative inflammatory complications such as pneumonia and lung trouble called adult respiratory distress syndrome (ARDS). This study will draw blood from trauma patients are several time points after their injury to see if we can predict who is at greatest risk for developing pneumonia or ARDS based upon the results of these immune lab tests. We are particularly interested to see if this will be useful in obese patients who have a greater risk of these post trauma complications


Condition
Trauma
Obesity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Immunoregulatory Dysfunction in Trauma Patients: Role of Obesity

Resource links provided by NLM:


Further study details as provided by University of Mississippi Medical Center:

Biospecimen Retention:   Samples Without DNA

Blood


Enrollment: 10
Study Start Date: November 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The role of inflammation in disease is increasingly appreciated in clinical medicine. Too much or too long a course of inflammation can lead to serious and sometime fatal complications for patients who experience significant physical trauma, particularly those whose injuries are serious enough to warrant intensive care follow up. On the other hand, the sheer stress of the traumatic injury can leave patients deficient in their ability to mount a protective immune/inflammatory response leaving them susceptible to concomitant infection. Another component to the conundrum is that after the trauma (first hit), the surgeons are faced with the dilemma of complete surgical repair of the injury - the second hit (i.e. full orthopedic repairs) vs stabilization of the injury until the patient recovers from the shock of the first hit. The difficulty for the medical team is predicting who can safely tolerate a full second hit (total surgical restoration) vs who needs to be further stabilized before further intervention. In the obese individual, this conundrum is compounded by the known immune/inflammatory alterations characteristic of the obese state. How these patients in particular can be safely triaged for immediate vs delayed definitive therapy based upon specific immune/inflammatory parameters is the object of this initial pilot study.

Hypothesis

Obese individuals who experience severe traumatic injury will develop immunoregulatory dysfunction shortly after injury that is greater than nonobese individuals experiencing similar traumatic injury. Depending upon severity and duration of this immunoregulatory dysfunction, the post injury inflammatory responses will also be altered resulting in increased risk for pneumonia and/or adult respiratory distress syndrome, major morbidities associated with trauma.

Specific Aims

  1. Determine immunoregulatory and inflammatory blood cytokine and endocrine stress hormone profiles in adult patients with significant traumatic injury correlated with subsequent development of pneumonia and/or adult respiratory distress syndrome.
  2. Examine the role of obesity in the initial immunoregulatory dysfunction and subsequent short term clinical course of trauma patients.
  3. Investigate whether demographic differences (age, gender, race) impact the risk for immunoregulatory and/or inflammatory dysfunction as well as risk for pneumonia and/or adult respiratory distress syndrome in obese s non obese trauma patients.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patient with significant traumatic injury

Criteria

Inclusion Criteria:

  1. age 18 and older
  2. traumatic injury of sufficient severity that ICU care is anticipated
  3. Likely (by clinical criteria) to survive for at least 7 days after enrollment

Exclusion Criteria:

  1. age less than 18 (not at risk for ARDS)
  2. minor trauma not requiring ICU monitoring
  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: NCT00833287

Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: George V Russell, M.D. University of Mississippi Medical Center
  More Information

No publications provided

Responsible Party: University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT00833287     History of Changes
Other Study ID Numbers: 2008-0126
Study First Received: January 30, 2009
Last Updated: April 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Mississippi Medical Center:
immunoregulatory
dysfunction
obesity

Additional relevant MeSH terms:
Obesity
Wounds and Injuries
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014