Longitudinal Monitoring of Inflammation in Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Cirrhosis, Liver

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Healthy controls

Healthy controls will receive the sensors

Group Type EXPERIMENTAL

Sensor skin

Intervention Type DIAGNOSTIC_TEST

Skin sensor to detect inflammatory molecules in sweat

Outpatients with cirrhosis

Outpatients with cirrhosis will receive the sensors

Group Type EXPERIMENTAL

Sensor skin

Intervention Type DIAGNOSTIC_TEST

Skin sensor to detect inflammatory molecules in sweat

Inpatients with cirrhosis

Inpatients with cirrhosis will receive the sensors

Group Type EXPERIMENTAL

Sensor skin

Intervention Type DIAGNOSTIC_TEST

Skin sensor to detect inflammatory molecules in sweat

Interventions

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Sensor skin

Skin sensor to detect inflammatory molecules in sweat

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

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)

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. Chronic diseases
3. Unable to come in daily or be available daily for 3 days.

Outpatients with Cirrhosis:

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:

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes