Longitudinal Monitoring of Inflammation in Cirrhosis

Cirrhosis, Liver Clinical Trial

Official title:

Longitudinal Monitoring of Inflammation in Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05538962
• Other study ID #: BAJAJ0028
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2023
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: Andrew Fagan
• Phone: 804 675 5000
• Email: andrew.fagan[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Fibrosis
• Inflammation
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Sensor skin
Skin sensor to detect inflammatory molecules in sweat

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Linkage of inflammatory markers with MELD score	Correlation of inflammatory markers using the skin sensor data to MELD score	3 days