Clinical trial NCT05538962: Longitudinal Monitoring of Inflammation in Cirrhosis
Official title: Longitudinal Monitoring of Inflammation in Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis, Liver
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2022-09-14
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 days
Secondary outcomes:
measure: Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values
timeFrame: 3 days
measure: Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life
timeFrame: 3 days
measure: Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing
timeFrame: 3 days
measure: Linkage of inflammatory markers with MELD score
timeFrame: 3 days
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes McGuire VAMC
name: Jasmohan Bajaj, MD
role: PRINCIPAL_INVESTIGATOR
References: