Immunoregulatory Dysfunction in Trauma Patients: Role of Obesity (ObesityRole)
|ClinicalTrials.gov Identifier: NCT00833287|
Recruitment Status : Terminated (Enrollment process not efficient)
First Posted : February 2, 2009
Last Update Posted : April 6, 2012
|Condition or disease|
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.
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.
- 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.
- Examine the role of obesity in the initial immunoregulatory dysfunction and subsequent short term clinical course of trauma patients.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||10 participants|
|Official Title:||Immunoregulatory Dysfunction in Trauma Patients: Role of Obesity|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833287
|Principal Investigator:||George V Russell, M.D.||University of Mississippi Medical Center|