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Longitudinal Monitoring of Inflammation in Cirrhosis

Primary Purpose

Cirrhosis, Liver

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sensor skin
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cirrhosis, Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Healthy Volunteers

Inclusion Criteria:

  1. Age >18 years
  2. Able to give consent

Exclusion Criteria:

  1. Unable/unwilling to consent
  2. Chronic diseases
  3. Unable to come in daily or be available daily for 3 days.

Outpatients with Cirrhosis:

Inclusion criteria:

  1. Age >18 years
  2. Able to give consent

  3. Cirrhosis defined by any one of the following

    1. Cirrhosis on liver biopsy or transient wave elastography
    2. Nodular liver on imaging
    3. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
    4. Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
    5. Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)

Exclusion criteria:

  1. Unable/unwilling to consent
  2. Unclear diagnosis of cirrhosis
  3. Unable to come in daily or be available daily for 3 days.
  4. Inflammatory bowel disease or other diseases that require immunosuppressive therapy use

Inpatients with Cirrhosis:

Inclusion criteria:

  1. Age >18 years
  2. Able to give consent

  3. Cirrhosis defined by any one of the following

    1. Cirrhosis on liver biopsy or transient wave elastography
    2. Nodular liver on imaging
    3. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
    4. Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease
    5. Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)

Exclusion criteria:

  1. Unable/unwilling to consent
  2. Unclear diagnosis of cirrhosis
  3. Unable to be seen daily or able to come in daily for 3 days (if discharged in between)
  4. Inflammatory bowel disease or other diseases that require immunosuppressive therapy use

Sites / Locations

  • Hunter Holmes McGuire VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy controls

Outpatients with cirrhosis

Inpatients with cirrhosis

Arm Description

Healthy controls will receive the sensors

Outpatients with cirrhosis will receive the sensors

Inpatients with cirrhosis will receive the sensors

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
We will study whether subjects have any issues or adverse events related to the sensor

Secondary Outcome Measures

Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values
Comparison of skin sensor data to blood inflammatory markers as above using daily blood draw and sensor values. Blood markers and sensor markers will be correlated for each day.
Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life
Correlation of inflammatory markers using the skin sensor data to quality of life using Sickness Impact Profile and PROMIS questionnaires.
Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing
Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop
Linkage of inflammatory markers with MELD score
Correlation of inflammatory markers using the skin sensor data to MELD score

Full Information

First Posted
September 7, 2022
Last Updated
September 18, 2023
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05538962
Brief Title
Longitudinal Monitoring of Inflammation in Cirrhosis
Official Title
Longitudinal Monitoring of Inflammation in Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Longitudinal monitoring of inflammation using skin devices may help predict outcomes compared to traditional blood draws

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Liver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
Healthy controls will receive the sensors
Arm Title
Outpatients with cirrhosis
Arm Type
Experimental
Arm Description
Outpatients with cirrhosis will receive the sensors
Arm Title
Inpatients with cirrhosis
Arm Type
Experimental
Arm Description
Inpatients with cirrhosis will receive the sensors
Intervention Type
Diagnostic Test
Intervention Name(s)
Sensor skin
Intervention Description
Skin sensor to detect inflammatory molecules in sweat
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
We will study whether subjects have any issues or adverse events related to the sensor
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values
Description
Comparison of skin sensor data to blood inflammatory markers as above using daily blood draw and sensor values. Blood markers and sensor markers will be correlated for each day.
Time Frame
3 days
Title
Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life
Description
Correlation of inflammatory markers using the skin sensor data to quality of life using Sickness Impact Profile and PROMIS questionnaires.
Time Frame
3 days
Title
Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing
Description
Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop
Time Frame
3 days
Title
Linkage of inflammatory markers with MELD score
Description
Correlation of inflammatory markers using the skin sensor data to MELD score
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy Volunteers Inclusion Criteria: Age >18 years Able to give consent Exclusion Criteria: Unable/unwilling to consent Chronic diseases Unable to come in daily or be available daily for 3 days. Outpatients with Cirrhosis: Inclusion criteria: Age >18 years Able to give consent Cirrhosis defined by any one of the following Cirrhosis on liver biopsy or transient wave elastography Nodular liver on imaging Endoscopic or radiological evidence of varices in a patient with chronic liver disease Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome) Exclusion criteria: Unable/unwilling to consent Unclear diagnosis of cirrhosis Unable to come in daily or be available daily for 3 days. Inflammatory bowel disease or other diseases that require immunosuppressive therapy use Inpatients with Cirrhosis: Inclusion criteria: Age >18 years Able to give consent Cirrhosis defined by any one of the following Cirrhosis on liver biopsy or transient wave elastography Nodular liver on imaging Endoscopic or radiological evidence of varices in a patient with chronic liver disease Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome) Exclusion criteria: Unable/unwilling to consent Unclear diagnosis of cirrhosis Unable to be seen daily or able to come in daily for 3 days (if discharged in between) Inflammatory bowel disease or other diseases that require immunosuppressive therapy use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Fagan
Phone
804 675 5000
Ext
2991
Email
andrew.fagan@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Travis Mousel
Phone
804 675 5000
Ext
4330
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan Bajaj, MD
Organizational Affiliation
Hunter Holmes McGuire VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Fagan
Phone
804-675-5000
Ext
2991
Email
andrew.fagan@va.gov
First Name & Middle Initial & Last Name & Degree
Travis Mousel
Phone
804 675 5000
Email
travis.mousel@va.gov
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MBBS, MD, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Longitudinal Monitoring of Inflammation in Cirrhosis

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