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

43611

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.

2019-02-28

2023-06-20

2023-06-20

Completed

Early phase I

70

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Compare the effectiveness of a NSAID to placebo in acute trauma setting.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Participant medical team will be blinded to the treatment or placebo intervention', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

2023-09-21