Longitudinal Monitoring of Inflammation in Cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis, Liver
• Interventions: Diagnostic Test: Sensor skin

• Registration Number: NCT05538962
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-14
• Primary Completion: 2023-09-01
• Status Verified: 2024-07
• Study Completion: 2024-07-31
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inpatients with cirrhosis	Sensor skin	Inpatients with cirrhosis will receive the sensors
Healthy controls	Sensor skin	Healthy controls will receive the sensors
Outpatients with cirrhosis	Sensor skin	Outpatients with cirrhosis will receive the sensors

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 days	We will study whether subjects have any issues or adverse events related to the sensor

Secondary Outcome Measures

Name	Time	Method
Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values	3 days	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	3 days	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	3 days	Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop
Linkage of inflammatory markers with MELD score	3 days	Correlation of inflammatory markers using the skin sensor data to MELD score

Trial Locations

Locations (1)

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States