The Impact of Liver Cirrhosis on Outcomes in Trauma 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. We hypothesize that trauma patients with cirrhosis will have higher rates of mortality and infectious complications.

Study Overview

• Status: Completed
• Conditions: Cirrhosis

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 Type: Observational
• Enrollment (Actual): 4774035

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Patient death	2010-2018
Incidence of infectious complications	Incidents of complications with infections	2010-2018

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Parvez Mantry, MD, Methodist Dallas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): September 4, 2020
• Study Completion (Actual): September 4, 2020

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cirrhotic trauma
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 042.HEP.2018.D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No