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Longitudinal Monitoring of Inflammation in Cirrhosis

Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05538962
Collaborator
(none)
60
Enrollment
1
Location
3
Arms
15
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sensor skin
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
All subjects will receive the sensor but they are 3 different populations, which is why there are 3 different armsAll subjects will receive the sensor but they are 3 different populations, which is why there are 3 different arms
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Longitudinal Monitoring of Inflammation in Cirrhosis
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Healthy controls

Healthy controls will receive the sensors

Diagnostic Test: Sensor skin
Skin sensor to detect inflammatory molecules in sweat
Experimental: Outpatients with cirrhosis

Outpatients with cirrhosis will receive the sensors

Diagnostic Test: Sensor skin
Skin sensor to detect inflammatory molecules in sweat
Experimental: Inpatients with cirrhosis

Inpatients with cirrhosis will receive the sensors

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. Linkage of inflammatory markers with MELD score [3 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

  4. Cirrhosis on liver biopsy or transient wave elastography

  5. Nodular liver on imaging

  6. Endoscopic or radiological evidence of varices in a patient with chronic liver disease

  7. Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease

  8. 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

  4. Cirrhosis on liver biopsy or transient wave elastography

  5. Nodular liver on imaging

  6. Endoscopic or radiological evidence of varices in a patient with chronic liver disease

  7. Platelet count <150,000/mm3 and AST/ALT ratio >1 in a patient with chronic liver disease

  8. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunter Holmes McGuire VA Medical Center Richmond Virginia United States 23249

Sponsors and Collaborators

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigators

  • Principal Investigator: Jasmohan Bajaj, MD, Hunter Holmes McGuire VAMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT05538962
Other Study ID Numbers:
  • BAJAJ0028
First Posted:
Sep 14, 2022
Last Update Posted:
Sep 14, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Cirrhosis
Inflammation
Fibrosis

Study Results

No Results Posted as of Sep 14, 2022