Alcoholic HepatitisNCT05594953
Outcomes Using MARS for Patients With ALF
An observational study of Alcoholic Hepatitis and Acute Liver Failure, run by Methodist Health System at 1 site in United States.
Trial summary
Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcoholic Hepatitis, Acute Liver Failure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2021to 12 May 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients meeting the inclusion criteria (Alcoholic hepatitis, AoCLF; or ALF who underwent at least one round of dialysis using plasma exchange or MARS from January 1, 2019 to December 15, 2020 will be included in the analysis.
Who may be able to join
- The patient was diagnosed with: Alcoholic hepatitis; AoCLF; OR Acute fulminant liver failure
- The patient underwent at least one round of dialysis using plasma exchange or MARSTM
Who cannot join
- Patient not meeting the inclusion criteria will be excluded.
- All patients who underwent MARS at MDMC will be included in the study population.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Outcomes Using MARS: A Single Center Experience
Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures.
Read the detailed description
Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures. Patient's charts will be accessed on EPIC by the PI or delegated study personnel. The investigator's anticipate completion of this study by January 31, 2022.
- Conditions
- Alcoholic Hepatitis, Acute Liver Failure
- Medical subject headings
- Hepatitis, Alcoholic, Liver Failure, Acute
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival mortality
transplant will be measured by date of death, and discharge
Measured: Rate at 30 days
Difference in Demographics
co-morbidities, etiology of liver failure between those treated with MARS vs. controls
Measured: Rate at 30 days
Improvement in Transplant
Determine whether treatment with MARS can help facilitate improvement in HE, LOS, and ICU duration.
Measured: Rate at 30 days
Secondary outcomes (7)
Demographics
age (years), gender (male/female), race (Caucasian, black, Hispanic, Asian, other), BMI (kg/m2)
Measured: January 1, 2019 to January 31, 2022
Hepatorenal syndrome
Y/N
Measured: (in hospital [date of death or discharge or transplant]) and at 30 days
Need for vasopressor support
Y/N
Measured: (in hospital [date of death or discharge or transplant]) and at 30 days
Sepsis (as measured by by QSOFA criteria):
Y/N
Measured: (in hospital [date of death or discharge or transplant]) and at 30 days
Need for CRRT as documented in the chart:
Y/N
Measured: (in hospital [date of death or discharge or transplant]) and at 30 days
ICU duration
days of date of ICU duration
Measured: date of ICU admission and date of discharge (or death)
long term dialysis
Need for long term dialysis (Y/N)
Measured: (in hospital [date of death or discharge or transplant]) and at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start23 Apr 2021
- Primary completion12 May 2026
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic HepatitisStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 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, Methodist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05594953
- Sponsor's protocol ID
- 075.HEP.2020.D
- Status last verified
- Jul 2023
- First submitted
- 3 Feb 2022
- Last updated
- 11 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes Using MARS: A Single Center Experience
- ClinicalTrials.gov ID
- NCT05594953
- Acronym / sponsor ID
- 075.HEP.2020.D
- Conditions
- Alcoholic Hepatitis, Acute Liver Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 26 Oct 2022 (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.
Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures.
Detailed description
Retrospective chart review will be conducted on patients at Methodist Dallas Medical Center, meeting the inclusion criteria from January 1, 2019 to December 15, 2020 to determine the transplant free survival and overall survival and other secondary outcome measures. Patient's charts will be accessed on EPIC by the PI or delegated study personnel. The investigator's anticipate completion of this study by January 31, 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients meeting the inclusion criteria (Alcoholic hepatitis, AoCLF; or ALF who underwent at least one round of dialysis using plasma exchange or MARS from January 1, 2019 to December 15, 2020 will be included in the analysis.
Key inclusion criteria (2 listed)
- The patient was diagnosed with: Alcoholic hepatitis; AoCLF; OR Acute fulminant liver failure
- The patient underwent at least one round of dialysis using plasma exchange or MARSTM
Key exclusion criteria (2 listed)
- Patient not meeting the inclusion criteria will be excluded.
- All patients who underwent MARS at MDMC will be included in the study population.
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
Transplant free survival mortality
Time frame: Rate at 30 days
transplant will be measured by date of death, and discharge
Difference in Demographics
Time frame: Rate at 30 days
co-morbidities, etiology of liver failure between those treated with MARS vs. controls
Improvement in Transplant
Time frame: Rate at 30 days
Determine whether treatment with MARS can help facilitate improvement in HE, LOS, and ICU duration.
7 secondary outcomes
Demographics
Time frame: January 1, 2019 to January 31, 2022
Hepatorenal syndrome
Time frame: (in hospital [date of death or discharge or transplant]) and at 30 days
Need for vasopressor support
Time frame: (in hospital [date of death or discharge or transplant]) and at 30 days
Sepsis (as measured by by QSOFA criteria):
Time frame: (in hospital [date of death or discharge or transplant]) and at 30 days
Need for CRRT as documented in the chart:
Time frame: (in hospital [date of death or discharge or transplant]) and at 30 days
ICU duration
Time frame: date of ICU admission and date of discharge (or death)
long term dialysis
Time frame: (in hospital [date of death or discharge or transplant]) and at 30 days
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 11 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
Methodist
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 Alcoholic Hepatitis and Acute Liver Failure, 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 2 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 11 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?
Transplant free survival mortality (time frame: Rate at 30 days). The study lists 3 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 11 Jun 2026.