Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch

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The goal of this observational study is to learn about the utility of biopatches predicting 30-day readmissions in patients discharged from the hospital with sepsis. The main question\[s\] it aims to answer are: • Does the application of a biopatch provide data that can improve prediction of an unplanned 30-day readmission following a hospitalization for sepsis. Participants will be asked to wear a biopatch on their chest for 30-days following hospital discharge or until readmission to the hospital.

Conditions:

🦠 Sepsis

🗓️ Study Start (Actual) 1 May 2023

🗓️ Primary Completion (Estimated) 1 May 2027

✅ Study Completion (Estimated) 2 May 2027

👥 Enrollment (Estimated) 200

🔬 Study Type OBSERVATIONAL

📊 Phase N/A

Locations:

📍 San Diego, California, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

Age \>= 18 years Development of sepsis, defined by recent international guidelines (Suspected infection AND 2-point change in sequential organ failure assessment (SOFA) score), in emergency department or hospital Admission to hospital from emergency department

Exclusion Criteria:

Transition to comfort measures within 6 hours of time of sepsis Discharge from the emergency department Admission to bone marrow transplant service Severe burn or other dermatologic condition that will prevent application to skin

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 28 March 2023
First Submitted that Met QC Criteria 28 March 2023
First Posted 10 April 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 1 April 2024
Last Update Posted 3 April 2024
Last Verified April 2024