Longitudinal Monitoring of Inflammation in Cirrhosis

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Diagnostic test: Sensor skin

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy controls; Healthy controls will receive the sensors	Diagnostic test: Sensor skin; Skin sensor to detect inflammatory molecules in sweat
Experimental: Outpatients with cirrhosis; Outpatients with cirrhosis will receive the sensors	Diagnostic test: Sensor skin; Skin sensor to detect inflammatory molecules in sweat
Experimental: Inpatients with cirrhosis; Inpatients with cirrhosis will receive the sensors	Diagnostic test: Sensor skin; Skin sensor to detect inflammatory molecules in sweat

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

Collaborators and Investigators

• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Investigators: Principal Investigator: Jasmohan Bajaj, MD, Hunter Holmes McGuire VAMC

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: July 31, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Inflammation; Liver Cirrhosis
• Other Study ID Numbers: BAJAJ0028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No