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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05594953
Other study ID # 075.HEP.2020.D
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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