Clinical trial NCT05170854: The Impact of Liver Cirrhosis on Outcomes in Trauma Patients
Official title: The Impact of Liver Cirrhosis on Outcomes in Trauma Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cirrhosis
Keywords: cirrhotic trauma
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 4774035
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed diagnosis of cirrhosis via radiologic, laboratory profile and intraoperative findings will be selected.Data will be extracted from the NTDB \& TQIP databanks from 2010-2018.

Brief summary: Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. We hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Detailed description: There have been a select few studies addressing the effects of cirrhosis on trauma patients. These studies show an increase in morbidity and mortality. However, there is limitation in the depth and breadth of analysis. The primary aim of this study is to determine the mortality rates in cirrhotic trauma patients with a secondary end-point being the determination of the incidence of infections associated with these patients.

Given that there are only a few studies on the effects of cirrhosis on trauma patients and none have addressed the impact cirrhosis has on the incidence of infections, it is important that we study this to determine the mortality in cirrhotic trauma patients and ascertain the incidence of infectious complications in these patients. PI hypothesizes that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Eligibility criteria: Inclusion Criteria:

* Cirrhotic trauma patients in the United States within 2010-2018
* Patients ≥ 18 years old

Exclusion Criteria:

* Patients less than 18 years old

Primary outcomes:
measure: Mortality
timeFrame: 2010-2018
measure: Incidence of infectious complications
timeFrame: 2010-2018
Secondary outcomes:
measure: Patient demographics
timeFrame: 2010-2018
measure: vital signs; clinical measurements
timeFrame: 2010-2018
measure: vital signs; pulse rate
timeFrame: 2010-2018
measure: vital signs; temperature
timeFrame: 2010-2018
measure: vital signs; respiration rate
timeFrame: 2010-2018
measure: vital signs; blood pressure
timeFrame: 2010-2018
measure: injury characteristics
timeFrame: 2010-2018
measure: hospital and ICU lengths of stay
timeFrame: 2010-2018
measure: transfusion data
timeFrame: 2010-2018
measure: alcohol use indicator
timeFrame: 2010-2018
measure: drug use indicator
timeFrame: 2010-2018
measure: ventilator days
timeFrame: 2010-2018
measure: Abbreviated Injury Scale
timeFrame: 2010-2018
measure: Glasgow Coma Scale
timeFrame: 2010-2018
measure: Injury Severity Score
timeFrame: 2010-2018
measure: discharge date
timeFrame: 2010-2018
measure: arrival date
timeFrame: 2010-2018
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Health System
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Parvez Mantry, MD
role: PRINCIPAL_INVESTIGATOR
References: