Inflammatory Markers in Trauma Patient Outcomes
Кључне речи
Апстрактан
Опис
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.
Датуми
| Последња верификација: | 10/31/2019 |
| Фирст Субмиттед: | 09/11/2018 |
| Предвиђена пријава послата: | 09/12/2018 |
| Прво објављено: | 09/13/2018 |
| Послато последње ажурирање: | 11/06/2019 |
| Последње ажурирање објављено: | 11/11/2019 |
| Стварни датум почетка студије: | 01/31/2019 |
| Процењени датум примарног завршетка: | 08/31/2021 |
| Предвиђени датум завршетка студије: | 08/31/2022 |
Стање или болест
Интервенција / лечење
Drug: Standard of Care with NSAID
Drug: Standard of Care without NSAID
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Placebo Comparator: Standard of Care without NSAID Polytrauma participants will receive standard of care in addition to saline solution according to standard ATLS and standard ICU routine medical care. | Drug: Standard of Care without NSAID Participants will receive 10 ml of saline solution IV every 6 hours for their first 5 days of hospitalization |
| Experimental: Standard of Care with NSAID Participants in the group will receive Ketorolac in addition to standard of care for the standard ATLS or ICU routine medical care. | Drug: Standard of Care with NSAID Participants will receive Ketorolac at 30 mg IV every 6 hours for their first 5 days of hospitalization |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | 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. |
Исход
Примарне мере исхода
1. Length of Hospital Stay [Up to 30 days]
Секундарне мере исхода
1. Change in Interleukin 1 [baseline and day 1, 2, 3 ,4 and 5]
2. Change in Interleukin 6 [baseline and day 1, 2, 3 ,4 and 5]
3. Change in Interleukin 10 [baseline and day 1, 2, 3 ,4 and 5]
4. Change in Prostaglandin E-2 [baseline and day 1, 2, 3 ,4 and 5]
5. Post Traumatic Complications [Up to 30 days]
6. Mortality [Up to 30 days]
7. Change in Patient Pain Scores [Up to 30 days]
8. Morphine Milligram Equivalents in House [Up to 30 days]
9. Change in Inpatient Subjective Pain Reports [up to 30 days]
10. Change in Outpatient Subjective Pain Reports [up to 365 days]
