Inflammatory Markers in Trauma Patient Outcomes



Status:Not yet recruiting
Healthy:No
Age Range:18 - 65
Updated:9/28/2018
Start Date:October 2019
End Date:September 2022
Contact:Paul Stringer, CCRP
Email:Paul.stringer@uky.edu
Phone:859-218-3138

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Inflammatory Response to Trauma - Does Early Cytokine Modulation Improve Patient Outcome

It is unknown whether early modulation of inflammatory cytokines is associated with improved
patient outcomes, reduced narcotic requirements in orthopaedic patient population, and
improved patient subjective pain after hospital discharge. Preliminary animal and clinical
studies have shown correlation between elevated blood cytokine concentrations during the
acute phase of trauma and the development of post-traumatic complications. Early
administration of nonsteroidal anti-inflammatory drug (NSAID) in animals significantly
reduced inflammatory profiles, improved pulmonary edema, and enhanced arteriole
vasoconstriction in response to hemorrhage. The ability to modify post-traumatic physiologic
response via short-term administration of a non-steroidal anti-inflammatory drug (NSAID) may
lead to improved patient outcome. In addition, given the current landscape for opioid
epidemic in the United States, alternative non-opioid pain management during acute trauma has
the potential to reduce opioid consumption and represents a pivotal component of multimodal
analgesia strategy.

By doing this study, the investigators hope to learn how to provide the best care for all
patients in the state of Kentucky. Patient participation in this research will last about 1
year.

Accidental trauma is the 4th leading cause of death in the United States, and it is
associated with a complex inflammatory response. This response is associated with
post-traumatic complications such as; multi-organ dysfunction syndrome (MODS), bacterial
pneumonia, acute respiratory distress syndrome (ARDS), systemic inflammatory response
syndrome (SIRS), and post traumatic pain (PTP). It is unknown whether early modulation of
inflammatory cytokines is associated with improved patient outcomes, reduced narcotic
requirements, and improved patient subjective pain after hospital discharge.

Preliminary data has shown: (1) elevated blood cytokine concentrations during the acute phase
of trauma are correlated with the development of fatal post-traumatic complications, (2) that
early administration of a non-steroidal anti-inflammatory drug (NSAID) resulted in decreased
blood serum levels of IL-6, Prostaglandin E2 (PGE2), improved pulmonary edema, and enhanced
arterioles ability to vasoconstrict in response to hemorrhage in animal models, and (3) that
the addition of the internal physiologic parameters (inflammatory cytokines) to New Injury
Severity Score (NISS - a marker of the external anatomical insult) significantly improves the
ability to predict hospital length of stay of trauma patients when compared to NISS alone.
The investigator's group is the first to use an integrative approach that combines the
external anatomic injury data with the internal physiologic response for accurate prediction
of patient's clinical outcome. Therefore, if the investigators apply this same mindset to
treatment, the investigators can improve the trauma patients' care by addressing both
parameters as opposed to solely focusing on the external injury as done in the past. The
ability to modify post-traumatic physiologic response via short-term administration of a
NSAID may lead to improved patient outcome.

Over the last decade, clinicians remain puzzled over the safety of NSAID administration after
fracture in terms of bone union. In addition, given the current landscape for opioid epidemic
in the United States, alternative non-opioid pain management during acute trauma has the
potential to reduce opioid consumption and represents a pivotal component of multimodal
analgesia strategy.

Inclusion Criteria:

Exclusion Criteria:

- Patient age < 18 or > 65

- Patients with injury more than 24 hours prior to evaluation

- Hemorrhagic shock or risk of significant hemorrhage.

- Patients with preexisting inflammatory medical condition such as inflammatory
arthropathy or inflammatory bowel disease

- Patients with acquired immunodeficiency syndrome (AIDS)

- Patients who are pregnant

- Patients with active GI bleed or ulceration

- Patients with chronic use of steroids or immune modulating drugs or history of organ
transplantation

- Patients with preexisting chronic renal, liver, or lung disease

- Patients with history of myocardial infarctions

- Patients with chronic heart failure

- Patients with allergy to NSAID

- Patients with coagulation defects (Clotting factor deficiencies, thrombophilia, or any
bleeding disorder)

- Patients receiving chronic opioid therapy or treatment for opioid use disorder.
We found this trial at
2
sites
Winston-Salem, North Carolina 26157
Phone: 336-716-5457
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Lexington, Kentucky
859) 257-9000
Phone: 859-218-3138
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Lexington, KY
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