Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05806762

Conditions

Sepsis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BioIntellisense

Study Details

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

Study ID

NCT05806762

Start date

May 1, 2023

Status verified date

Apr, 2024

Completion date

May 2, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

BioIntellisense

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

Primary outcome measure

  • Hospital readmission [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Gabriel Wardi

6195436463gwardi@health.ucsd.edu

Locations

UC San Diego Health

Recruiting

San Diego, California, United States, 92103

Contacts

Gabriel Wardi

619-543-6463gwardi@health.ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 3, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-04-03.