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Outcomes Using MARS for Patients With ALF

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT05594953
Collaborator
(none)
30
Enrollment
1
Location
21.3
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Outcomes Using MARS: A Single Center Experience
    Actual Study Start Date :
    Apr 23, 2021
    Anticipated Primary Completion Date :
    Jan 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Patient Mortality [at 30 days]

      overall mortality

    Secondary Outcome Measures

    1. Demographics [January 1, 2019 to January 31, 2022]

      age (years), gender (male/female), race (Caucasian, black, Hispanic, Asian, other), BMI (kg/m2)

    2. Hepatorenal syndrome [(in hospital [date of death or discharge or transplant]) and at 30 days]

      Y/N

    3. Need for vasopressor support [(in hospital [date of death or discharge or transplant]) and at 30 days]

      Y/N

    4. Sepsis (as measured by by QSOFA criteria): [(in hospital [date of death or discharge or transplant]) and at 30 days]

      Y/N

    5. Need for CRRT as documented in the chart: [(in hospital [date of death or discharge or transplant]) and at 30 days]

      Y/N

    6. ICU duration [date of ICU admission and date of discharge (or death)]

      days of date of ICU duration

    7. long term dialysis [(in hospital [date of death or discharge or transplant]) and at 30 days]

      Need for long term dialysis (Y/N)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Dallas Medical Center Dallas Texas United States 75203

    Sponsors and Collaborators

    • Methodist Health System

    Investigators

    • Principal Investigator: Parvez Mantry, MD, Methodist

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Methodist Health System
    ClinicalTrials.gov Identifier:
    NCT05594953
    Other Study ID Numbers:
    • 075.HEP.2020.D
    First Posted:
    Oct 26, 2022
    Last Update Posted:
    Oct 26, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Failure
    Hepatitis, Alcoholic
    Liver Failure, Acute

    Study Results

    No Results Posted as of Oct 26, 2022