Outcomes Using MARS for Patients With ALF

March 26, 2024 updated by: Methodist Health System

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • Recruiting
        • Methodist Dallas Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

  • Patient not meeting the inclusion criteria will be excluded.

All patients who underwent MARS at MDMC will be included in the study population.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplant free survival mortality
Time Frame: Rate at 30 days
transplant will be measured by date of death, and discharge
Rate at 30 days
Difference in Demographics
Time Frame: Rate at 30 days
co-morbidities, etiology of liver failure between those treated with MARS vs. controls
Rate at 30 days
Improvement in Transplant
Time Frame: Rate at 30 days
Determine whether treatment with MARS can help facilitate improvement in HE, LOS, and ICU duration.
Rate at 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: January 1, 2019 to January 31, 2022
age (years), gender (male/female), race (Caucasian, black, Hispanic, Asian, other), BMI (kg/m2)
January 1, 2019 to January 31, 2022
Hepatorenal syndrome
Time Frame: (in hospital [date of death or discharge or transplant]) and at 30 days
Y/N
(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
Y/N
(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
Y/N
(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
Y/N
(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)
days of date of ICU duration
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
Need for long term dialysis (Y/N)
(in hospital [date of death or discharge or transplant]) and at 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Methodist Health System

Investigators

  • Principal Investigator: Parvez Mantry, MD, Methodist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 075.HEP.2020.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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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