Status:
NOT_YET_RECRUITING
Feasibility of Wearable Biosensors for Monitoring Daily Activity, Heart Rate, and Sleep Among Patients With Decompensated Cirrhosis
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
Liver Cirrhosis, Alcoholic
Eligibility:
All Genders
Brief Summary
In this protocol, the investigators will determine compliance, acceptability, and patient satisfaction regarding the use of remote monitors and summarize changes in activity over time among patients w...
Eligibility Criteria
Inclusion
- \- Patients with an admission diagnosis of decompensated cirrhosis based on Child-Turcotte-Pugh score of ≥ 7 or MELD-Na score ≥ 15, measured prior to discharge from the hospital. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on a stable corticosteroid dose for three months or more before study inclusion.
- 4.2 18 years or older 2.4.3 Ambulatory (use of walking aids, such as cane and rollator, is acceptable) 2.4.4 Have an understanding, ability, and willingness to fully comply with study procedures and restrictions as determined by the principal investigator.
- 4.5 Informed consent obtained from the subject and the ability of the subject to comply with the requirements of the study.
Exclusion
- 5.1 Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
- 5.2 Presence of advanced or terminal stage hepatocellular carcinoma 2.5.3 Patients with current extrahepatic malignancies including solid tumors and hematologic disorders 2.5.4 Patients with an ongoing ACLF (see diagnostic criteria in reference16) 2.5.5 Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including congestive heart failure New York Heart Association Grade III/IV, COPD GOLD \>2, chronic kidney disease defined by KDIGO criteria, or under renal replacement therapy.
- 5.6 Presence of any extra-hepatic malignancy not in remission for \> 12 months 2.5.7 Pregnancy, since being pregnant may alter heart rate and sleep patterns. Women of childbearing age remain eligible.
- 5.8 Inability or refusal to provide informed consent by the patient 2.5.9 Patients with hepatic encephalopathy New Haven grade 1 or greater. 2.5.10 Any records flagged "break the glass" or "research opt out."
Key Trial Info
Start Date :
April 10 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06057870
Start Date
April 10 2024
End Date
July 30 2025
Last Update
February 8 2024
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