Outcomes Using MARS for Patients With ALF

Alcoholic Hepatitis Clinical Trial

Official title:

Outcomes Using MARS: A Single Center Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05594953
• Other study ID #: 075.HEP.2020.D
• Status: Recruiting
• Start date: April 23, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Methodist Health System
• Contact: Crystee Cooper, DHEd
• Phone: 214-947-1280
• Email: clinicalresearch[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Liver Failure
• Alcoholic Hepatitis
• Hepatitis, Alcoholic
• Liver Failure
• Liver Failure, Acute

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival mortality	transplant will be measured by date of death, and discharge	Rate at 30 days
Primary	Difference in Demographics	co-morbidities, etiology of liver failure between those treated with MARS vs. controls	Rate at 30 days
Primary	Improvement in Transplant	Determine whether treatment with MARS can help facilitate improvement in HE, LOS, and ICU duration.	Rate at 30 days
Secondary	Demographics	age (years), gender (male/female), race (Caucasian, black, Hispanic, Asian, other), BMI (kg/m2)	January 1, 2019 to January 31, 2022
Secondary	Hepatorenal syndrome	Y/N	(in hospital [date of death or discharge or transplant]) and at 30 days
Secondary	Need for vasopressor support	Y/N	(in hospital [date of death or discharge or transplant]) and at 30 days
Secondary	Sepsis (as measured by by QSOFA criteria):	Y/N	(in hospital [date of death or discharge or transplant]) and at 30 days
Secondary	Need for CRRT as documented in the chart:	Y/N	(in hospital [date of death or discharge or transplant]) and at 30 days
Secondary	ICU duration	days of date of ICU duration	date of ICU admission and date of discharge (or death)
Secondary	long term dialysis	Need for long term dialysis (Y/N)	(in hospital [date of death or discharge or transplant]) and at 30 days