SepsisNCT05806762
Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch
An observational study of Sepsis, run by University of California, San Diego at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- BioIntellisense
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 2 May 2027
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shamim Nemati contact
United States1 site, 1 recruiting
- Recruiting
UC San Diego Health
San Diego, California, 92103
Gabriel Wardi, 619-543-6463, gwardi@health.ucsd.edu
About this study
Official title: Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch and Deep Learning Model
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.
Read the detailed description
Study Design: Longitudinal cohort study with repeated measure of outcomes and predictors.
The BioIntelliSense patch is an FDA approved wearable device that is applied to the chest with a 30-day battery lifespan and allows for real-time monitoring of heart rate, respiratory rate, skin temperature, general activity, severe cough episodes, and sedentary body position, among others.
Outcomes of Interest: Hospital readmission within 30 days of discharge following an index admission with a diagnosis of sepsis is the primary outcome of interest for this study. We will calculate the positive predictive value (PPV) of readmission prediction as the the primary outcome of interest from the following approaches: analytic score plus biopatch, analytic score alone, LACE+ score. Secondary outcomes include area under the curve of the receiver operator characteristic (AUCroc) of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score) and number of patients readmitted to the hospital within 30 days of discharge.
Protocol for Patient Selection and Application of Biopatch: Patients who meet "Sepsis 3" definition will be identified with institutional review board (IRB)-approved screening protocols. Our previously derived and validated machine-learning algorithm to predict unplanned 30-day readmissions will then generate daily predictions about 30-day readmission probability which will be recorded, as well as LACE+ scores. As a patient approaches discharge, the treatment team and patient (or legally authorized representative) will be approached about potential enrollment. If there is agreement to enroll in this prospective study, then we will apply the patch at the time of discharge. Patients will then be followed with the BioIntellisence patch with augmented and real-time risk predictions based on data obtained from this. For this proposal, we will use data from the BioIntelliSense patch and are not providing clinicians with data on risk of readmission.
- Conditions
- Sepsis
- Being tested
- BioIntellisense
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioIntellisenseDevice
Enrolled patients will have a Fitbit placed on their wrist. There is no comparator group enrolled.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BioIntellisense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital readmission
Patients with an index hospitalization with sepsis will be followed to see if they have an unplanned readmission to the hospital.
Measured: 30 days
Secondary outcomes (2)
Area under the curve of the receiver operating characteristic
AUCroc of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score)
Measured: 30 days
Positive predictive value
PPV of of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 May 2023
- Primary completion1 May 2027 (estimated)
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Wardi, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806762
- Sponsor's protocol ID
- Gabriel.Wardi
- Status last verified
- Apr 2024
- First submitted
- 28 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data abstracted from the BioIntellisense biopatch will be shared with my K23 mentorship team as well trainees that are working with me on this project. All study members will be listed on the IRB. De-identified data may be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Rehospitalization Following a Sepsis Admission Using a Wearable Biopatch and Deep Learning Model
- ClinicalTrials.gov ID
- NCT05806762
- Acronym / sponsor ID
- Gabriel.Wardi
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 10 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design: Longitudinal cohort study with repeated measure of outcomes and predictors.
The BioIntelliSense patch is an FDA approved wearable device that is applied to the chest with a 30-day battery lifespan and allows for real-time monitoring of heart rate, respiratory rate, skin temperature, general activity, severe cough episodes, and sedentary body position, among others.
Outcomes of Interest: Hospital readmission within 30 days of discharge following an index admission with a diagnosis of sepsis is the primary outcome of interest for this study. We will calculate the positive predictive value (PPV) of readmission prediction as the the primary outcome of interest from the following approaches: analytic score plus biopatch, analytic score alone, LACE+ score. Secondary outcomes include area under the curve of the receiver operator characteristic (AUCroc) of predictive scores (analytic score and biopatch, analytic score alone, LACE+ score) and number of patients readmitted to the hospital within 30 days of discharge.
Protocol for Patient Selection and Application of Biopatch: Patients who meet "Sepsis 3" definition will be identified with institutional review board (IRB)-approved screening protocols. Our previously derived and validated machine-learning algorithm to predict unplanned 30-day readmissions will then generate daily predictions about 30-day readmission probability which will be recorded, as well as LACE+ scores. As a patient approaches discharge, the treatment team and patient (or legally authorized representative) will be approached about potential enrollment. If there is agreement to enroll in this prospective study, then we will apply the patch at the time of discharge. Patients will then be followed with the BioIntellisence patch with augmented and real-time risk predictions based on data obtained from this. For this proposal, we will use data from the BioIntelliSense patch and are not providing clinicians with data on risk of readmission.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis Patients Discharged From the Hospital | – | Device: BioIntellisenseWe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioIntellisenseEnrolled patients will have a Fitbit placed on their wrist. There is no comparator group enrolled. | Device | Sepsis Patients Discharged From the Hospital |
Primary outcome
Hospital readmission
Time frame: 30 days
Patients with an index hospitalization with sepsis will be followed to see if they have an unplanned readmission to the hospital.
2 secondary outcomes
Area under the curve of the receiver operating characteristic
Time frame: 30 days
Positive predictive value
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Yes. Data abstracted from the BioIntellisense biopatch will be shared with my K23 mentorship team as well trainees that are working with me on this project. All study members will be listed on the IRB. De-identified data may be shared with other researchers.
Related trials for Sepsis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shamim Nemati contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel Wardi (6195436463, gwardi@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital readmission (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.