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Completed

NCT Number: NCT05538962

Longitudinal Monitoring of Inflammation in Cirrhosis

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy Volunteers

Inclusion criteria

  • Age >18 years
  • Able to give consent

Exclusion criteria

  • Unable/unwilling to consent
  • Chronic diseases
  • Unable to come in daily or be available daily for 3 days.

Outpatients with Cirrhosis:

Inclusion criteria

  • 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)

Exclusion criteria

  • Unable/unwilling to consent
  • Unclear diagnosis of cirrhosis
  • Unable to come in daily or be available daily for 3 days.
  • Inflammatory bowel disease or other diseases that require immunosuppressive therapy use

Inpatients with Cirrhosis:

Inclusion criteria

  • 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)

Exclusion criteria

  • Unable/unwilling to consent
  • Unclear diagnosis of cirrhosis
  • Unable to be seen daily or able to come in daily for 3 days (if discharged in between)
  • Inflammatory bowel disease or other diseases that require immunosuppressive therapy use

Treatment and study plan

Sensor skin

Diagnostic Test

Skin sensor to detect inflammatory molecules in sweat

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 3 days

    We will study whether subjects have any issues or adverse events related to the sensor

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 3 days

    Correlation of inflammatory markers using the skin sensor data to quality of life using Sickness Impact Profile and PROMIS questionnaires.

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

    Time frame: 3 days

    Correlation of inflammatory markers using the skin sensor data to cognitive performance on PHES and EncephalApp Stroop

  4. Linkage of inflammatory markers with MELD score

    Time frame: 3 days

    Correlation of inflammatory markers using the skin sensor data to MELD score

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Sep 14, 2022
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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