The Impact of Liver Cirrhosis on Outcomes in Trauma Patients

Cirrhosis Clinical Trial

Official title:

The Impact of Liver Cirrhosis on Outcomes in Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05170854
• Other study ID #: 042.HEP.2018.D
• Status: Completed
• Start date: October 16, 2018
• Est. completion date: September 4, 2020

Study information

• Verified date: February 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4774035
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients less than 18 years old

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Locations

Country	Name	City	State
United States	Methodist Health System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patient death	2010-2018
Primary	Incidence of infectious complications	Incidents of complications with infections	2010-2018
Secondary	Patient demographics	demographics of patients	2010-2018
Secondary	vital signs; clinical measurements	clinical measurements	2010-2018
Secondary	vital signs; pulse rate	pulse rate (bpm)	2010-2018
Secondary	vital signs; temperature	temperature	2010-2018
Secondary	vital signs; respiration rate	respiration rate	2010-2018
Secondary	vital signs; blood pressure	blood pressure	2010-2018
Secondary	injury characteristics	characteristics of injuries	2010-2018
Secondary	hospital and ICU lengths of stay	length of days patients stays in hospital/ICU	2010-2018
Secondary	transfusion data	data regarding transfusions	2010-2018
Secondary	alcohol use indicator	indicator of alcohol use	2010-2018
Secondary	drug use indicator	indicator of drug use	2010-2018
Secondary	ventilator days	days on ventilator	2010-2018
Secondary	Abbreviated Injury Scale	abbreviated injury scale score	2010-2018
Secondary	Glasgow Coma Scale	glasgow coma scale score	2010-2018
Secondary	Injury Severity Score	score of injury	2010-2018
Secondary	discharge date	date of discharge	2010-2018
Secondary	arrival date	date of arrival	2010-2018