Longitudinal Monitoring of Inflammation in Cirrhosis

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

Official Title
-----------------
Longitudinal Monitoring of Inflammation in Cirrhosis

Conditions
-----------------
Cirrhosis, Liver

Intervention / Treatment
-----------------
* Diagnostic Test: Sensor skin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy controls<br>Healthy controls will receive the sensors | Diagnostic Test: Sensor skin<br>* Skin sensor to detect inflammatory molecules in sweat<br>|
| Experimental: Outpatients with cirrhosis<br>Outpatients with cirrhosis will receive the sensors | Diagnostic Test: Sensor skin<br>* Skin sensor to detect inflammatory molecules in sweat<br>|
| Experimental: Inpatients with cirrhosis<br>Inpatients with cirrhosis will receive the sensors | Diagnostic Test: Sensor skin<br>* Skin sensor to detect inflammatory molecules in sweat<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 
| 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. | 3 days | 
| 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 | 3 days | 
| Linkage of inflammatory markers with MELD score | Correlation of inflammatory markers using the skin sensor data to MELD score | 3 days |