Longitudinal Monitoring of Inflammation in Cirrhosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05538962

Enrollment

Registered

2022-09-14

Start date

2022-09-01

Completion date

2024-07-31

Last updated

2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Liver

Brief summary

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

Interventions

DIAGNOSTIC_TESTSensor skin

Skin sensor to detect inflammatory molecules in sweat

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026