CirrhosisNCT05170854
The Impact of Liver Cirrhosis on Outcomes in Trauma Patients
An observational study of Cirrhosis, run by Methodist Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- How many people
- 4,774,035 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Cirrhotic trauma patients in the United States within 2010-2018
- Patients ≥ 18 years old
Who cannot join
- Patients less than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cirrhosis
- Keywords
- cirrhotic trauma
- Medical subject headings
- Fibrosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patient death
Measured: 2010-2018
Incidence of infectious complications
Incidents of complications with infections
Measured: 2010-2018
Secondary outcomes (17)
Patient demographics
demographics of patients
Measured: 2010-2018
vital signs; clinical measurements
clinical measurements
Measured: 2010-2018
vital signs; pulse rate
pulse rate (bpm)
Measured: 2010-2018
vital signs; temperature
temperature
Measured: 2010-2018
vital signs; respiration rate
respiration rate
Measured: 2010-2018
vital signs; blood pressure
blood pressure
Measured: 2010-2018
injury characteristics
characteristics of injuries
Measured: 2010-2018
hospital and ICU lengths of stay
length of days patients stays in hospital/ICU
Measured: 2010-2018
transfusion data
data regarding transfusions
Measured: 2010-2018
alcohol use indicator
indicator of alcohol use
Measured: 2010-2018
drug use indicator
indicator of drug use
Measured: 2010-2018
ventilator days
days on ventilator
Measured: 2010-2018
Abbreviated Injury Scale
abbreviated injury scale score
Measured: 2010-2018
Glasgow Coma Scale
glasgow coma scale score
Measured: 2010-2018
Injury Severity Score
score of injury
Measured: 2010-2018
discharge date
date of discharge
Measured: 2010-2018
arrival date
date of arrival
Measured: 2010-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start16 Oct 2018
- Primary completion3 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 4,774,035 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Parvez Mantry, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170854
- Sponsor's protocol ID
- 042.HEP.2018.D
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2019
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Liver Cirrhosis on Outcomes in Trauma Patients
- ClinicalTrials.gov ID
- NCT05170854
- Acronym / sponsor ID
- 042.HEP.2018.D
- Conditions
- Cirrhosis
- Keywords
- cirrhotic trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,774,035 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 3 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Cirrhotic trauma patients in the United States within 2010-2018
- Patients ≥ 18 years old
Key exclusion criteria (1 listed)
- Patients less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 2010-2018
Patient death
Incidence of infectious complications
Time frame: 2010-2018
Incidents of complications with infections
17 secondary outcomes
Patient demographics
Time frame: 2010-2018
vital signs; clinical measurements
Time frame: 2010-2018
vital signs; pulse rate
Time frame: 2010-2018
vital signs; temperature
Time frame: 2010-2018
vital signs; respiration rate
Time frame: 2010-2018
vital signs; blood pressure
Time frame: 2010-2018
injury characteristics
Time frame: 2010-2018
hospital and ICU lengths of stay
Time frame: 2010-2018
transfusion data
Time frame: 2010-2018
alcohol use indicator
Time frame: 2010-2018
drug use indicator
Time frame: 2010-2018
ventilator days
Time frame: 2010-2018
Abbreviated Injury Scale
Time frame: 2010-2018
Glasgow Coma Scale
Time frame: 2010-2018
Injury Severity Score
Time frame: 2010-2018
discharge date
Time frame: 2010-2018
arrival date
Time frame: 2010-2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Parvez Mantry, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 2010-2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.