Longitudinal Monitoring of Inflammation in Cirrhosis

NCT05538962 | Completed

• 1 other identifier: BAJAJ0028
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Ability to detect inflammatory markers (TNF, IL-1b, IL-6 and CRP) using skin sensor compared to blood values

  3 days

• Linkage of skin inflammatory markers (TNF, IL-6, IL-1b and CRP) with quality of life

  3 days

• Linkage of inflammatory markers (TNF, IL-6, IL-1b and CRP) with cognitive testing

  3 days

• Linkage of inflammatory markers with MELD score

  3 days

Study Arms (3)

Healthy controls

EXPERIMENTAL

Healthy controls will receive the sensors

Diagnostic Test: Sensor skin

Outpatients with cirrhosis

EXPERIMENTAL

Outpatients with cirrhosis will receive the sensors

Diagnostic Test: Sensor skin

Inpatients with cirrhosis

EXPERIMENTAL

Inpatients with cirrhosis will receive the sensors

Diagnostic Test: Sensor skin

Interventions

Sensor skin DIAGNOSTIC_TEST

Skin sensor to detect inflammatory molecules in sweat

Healthy controls; Inpatients with cirrhosis; Outpatients with cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Able to give consent

You may not qualify if:

• Unable/unwilling to consent
• Chronic diseases
• Unable to come in daily or be available daily for 3 days.
• Outpatients with Cirrhosis:
• Age \>18 years
• Able to give consent
• Cirrhosis defined by any one of the following
• Cirrhosis on liver biopsy or transient wave elastography
• Nodular liver on imaging
• Endoscopic or radiological evidence of varices in a patient with chronic liver disease
• Platelet count \<150,000/mm3 and AST/ALT ratio \>1 in a patient with chronic liver disease
• Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
• Unable/unwilling to consent
• Unclear diagnosis of cirrhosis
• Unable to come in daily or be available daily for 3 days.

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasmohan Bajaj, MD

  Hunter Holmes McGuire VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: July 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)