Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch

NCT05806762 | Recruiting FDA Device

• 1 other identifier: Gabriel.Wardi
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Hospital readmission

  Patients with an index hospitalization with sepsis will be followed to see if they have an unplanned readmission to the hospital.

  30 days

Secondary Outcomes (2)

• Area under the curve of the receiver operating characteristic

  30 days

• Positive predictive value

  30 days

Study Arms (1)

Sepsis Patients Discharged From the Hospital

We aim to apply a wearable biopatch to sepsis patients discharged from the hospital to determine if the additional data afforded by the biopatch can improve prediction of readmissions.

Device: BioIntellisense

Interventions

BioIntellisense DEVICE

Enrolled patients will have a Fitbit placed on their wrist. There is no comparator group enrolled.

Sepsis Patients Discharged From the Hospital

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the hospital from the emergency department at UC San Diego who have sepsis are eligible if they meet appropriate inclusion criteria. After screening is completed, possible subjects will be approached by the study team for enrollment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego Health

San Diego, California, 92103, United States

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gabriel Wardi

CONTACT

6195436463; gwardi@health.ucsd.edu

Shamim Nemati

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 2, 2027
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 5 years
• Access Criteria: Available upon reasonable request.

Locations

US (1)