Outcomes Using MARS for Patients With ALF

NCT05594953 | Completed

• 1 other identifier: 075.HEP.2020.D
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholic Hepatitis; Acute Liver Failure

Outcome Measures

Primary Outcomes (3)

• Transplant free survival mortality

  transplant will be measured by date of death, and discharge

  Rate at 30 days

• Difference in Demographics

  co-morbidities, etiology of liver failure between those treated with MARS vs. controls

  Rate at 30 days

• Improvement in Transplant

  Determine whether treatment with MARS can help facilitate improvement in HE, LOS, and ICU duration.

  Rate at 30 days

Secondary Outcomes (7)

• Demographics

  January 1, 2019 to January 31, 2022

• Hepatorenal syndrome

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

• Need for vasopressor support

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

• Sepsis (as measured by by QSOFA criteria):

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

• Need for CRRT as documented in the chart:

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic; Liver Failure, Acute

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Liver Failure; Hepatic Insufficiency

Study Officials

• Parvez Mantry, MD

  Methodist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: October 26, 2022
• Study Start: April 23, 2021
• Primary Completion: May 12, 2026
• Study Completion: May 12, 2026
• Last Updated: June 11, 2026

Record last verified: 2023-07

Locations

US (1)