An observational study in Trauma and Obesity, sponsored by University of Mississippi Medical Center. Terminated. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-04-06.
Sponsored by University of Mississippi Medical Center · Observational
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
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
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
This study's enrollment of 10 is below the median of 135 across 1,603 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →University of Mississippi Medical Center is the lead sponsor of 129 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.
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Adult patient with significant traumatic injury
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This study is terminated, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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