The Impact of Liver Cirrhosis on Outcomes in Trauma Patients

Active, not recruiting

• Conditions: Cirrhosis

• Registration Number: NCT05170854
• Lead Sponsor: Methodist Health System

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.

Study Timeline

• Study Start: 2018-10-16
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4774035

Inclusion Criteria

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

Exclusion Criteria

• Patients less than 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	2010-2018	Patient death
Incidence of infectious complications	2010-2018	Incidents of complications with infections

Secondary Outcome Measures

Name	Time	Method
Injury Severity Score	2010-2018	score of injury
discharge date	2010-2018	date of discharge
hospital and ICU lengths of stay	2010-2018	length of days patients stays in hospital/ICU
arrival date	2010-2018	date of arrival
alcohol use indicator	2010-2018	indicator of alcohol use
vital signs; pulse rate	2010-2018	pulse rate (bpm)
Glasgow Coma Scale	2010-2018	glasgow coma scale score
vital signs; respiration rate	2010-2018	respiration rate
injury characteristics	2010-2018	characteristics of injuries
transfusion data	2010-2018	data regarding transfusions
Patient demographics	2010-2018	demographics of patients
vital signs; clinical measurements	2010-2018	clinical measurements
vital signs; temperature	2010-2018	temperature
drug use indicator	2010-2018	indicator of drug use
ventilator days	2010-2018	days on ventilator
Abbreviated Injury Scale	2010-2018	abbreviated injury scale score
vital signs; blood pressure	2010-2018	blood pressure

Trial Locations

Locations (1)

Methodist Health System; 🇺🇸 Dallas, Texas, United States