Outcomes Using MARS for Patients With ALF

Recruiting

• Conditions: Alcoholic Hepatitis; Acute Liver Failure

• Registration Number: NCT05594953
• Lead Sponsor: Methodist Health System

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.

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 Timeline

• Study Start: 2021-04-23
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Status Verified: 2023-07
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Demographics	January 1, 2019 to January 31, 2022	age (years), gender (male/female), race (Caucasian, black, Hispanic, Asian, other), BMI (kg/m2)
Hepatorenal syndrome	(in hospital [date of death or discharge or transplant]) and at 30 days	Y/N
Need for vasopressor support	(in hospital [date of death or discharge or transplant]) and at 30 days	Y/N
Sepsis (as measured by by QSOFA criteria):	(in hospital [date of death or discharge or transplant]) and at 30 days	Y/N
ICU duration	date of ICU admission and date of discharge (or death)	days of date of ICU duration
Need for CRRT as documented in the chart:	(in hospital [date of death or discharge or transplant]) and at 30 days	Y/N
long term dialysis	(in hospital [date of death or discharge or transplant]) and at 30 days	Need for long term dialysis (Y/N)

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States