Longitudinal Monitoring of Inflammation in Cirrhosis

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status: Completed

Conditions: Cirrhosis, Liver

Treatments: Diagnostic Test: Sensor skin

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05538962

BAJAJ0028

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 3 patient groups

Healthy controls

Experimental group

Description:

Healthy controls will receive the sensors

Treatment:

Diagnostic Test: Sensor skin

Outpatients with cirrhosis

Experimental group

Description:

Outpatients with cirrhosis will receive the sensors

Treatment:

Diagnostic Test: Sensor skin

Inpatients with cirrhosis

Experimental group

Description:

Inpatients with cirrhosis will receive the sensors

Treatment:

Diagnostic Test: Sensor skin