SepsisNCT06099756
Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)
An observational study of Sepsis, run by Measure Labs, Inc. at 3 sites in United States.
Trial summary
This is an adaptive platform. This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sepsis
- How many people
- 2,000 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2023to Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized adults who have been diagnosed to include but not limited to sepsis and heart failure.
Who may be able to join
- Age 18 years or older
- Admitted to the hospital for 48 hours or greater
- Admitted with an index diagnoses of sepsis. We defined sepsis based on the 2018 Centers for Disease Control and Prevention's Adult Sepsis Event (ASE).
- [1] A subject must have an order for blood cultures, at least 4 qualifying antimicrobial days AND Evidence of at least 1 end organ dysfunction (new vasopressors, initiation of mechanical ventilation, doubling of serum creatinine (or GFR reduction by 50%), total bilirubin ≥ 2.0 mg/dl, an increase by 100% from baseline, platelet count < 100 cells/ul, and lactate ≥ 2.0.
- The adaptive design will allow the expansion into additional index hospitalization diagnosis (for example, heart failure exacerbation, sickle cell crises, COPD exacerbation, hip fractures, pneumonia, post surgical patients, diabetes mellitus)
Who cannot join
- Imminent death or anticipated death during index admission (to include comfort care or hospice)
- Patients due to be transferred to another acute care facility
- Participants not proficient with written and spoken English.
- Participants who do not have a smartphone and valid mobile number to receive text messages.
- Participants leaving the hospital against medical advice.
- Participants with essential tremor.
Show all 12Show fewer
- Participants deemed non-compliant or not suitable for the study due to cognitive impairment or serious mental health conditions as determined by the Principal Investigator.
- Participants unable to independently navigate and operate smartphone applications.
- Participants with diminished decision-making capability.
- Participants likely to not be available to complete all protocol-required procedures (e.g., Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.
- Participants with history or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or study team, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Vulnerable Subjects, this study will not enroll children < 18 years of age, pregnant women, or prisoners.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Duke Regional Hospital
Durham, North Carolina, 27704
Lana Wahid, MD, lana.wahid@duke.edu
Parisa Farahani, MD, MPH, 919-684-5670, parisa.farahani@duke.edu
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
Lana Wahid, MD, lana.wahid@duke.edu
Parisa Farahani, MD, MPH, 919-684-5670, parisa.farahani@duke.edu
- Recruiting
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
Lana Wahid, MD, lana.wahid@duke.edu
Parisa Farahani, MD, MPH, 919-684-5670, parisa.farahani@duke.edu
About this study
Official title: Discharge Readmission Analysis and Management in Sepsis (DReAMS-2): Augmenting Readmission Risk Models With Smartphone PPG Signals and Deep Learning, an Adaptive Platform
This is an adaptive platform. This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged. This information will be used to create a computer tool that will help predict a patient's risk of being readmitted into the hospital after being discharged.
Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message. Participants will receive the text messages twice a day. When the participant receives the text message, they will click on the link and follow the instructions. Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature. Additional questions will also be asked. After 30 days, the text messages will stop, and participation will be complete.
Read the detailed description
Patients admitted into the hospital for sepsis and other health conditions (see inclusion criteria) and planning to be discharged within 72 hours will be approached for this study. Once patient agrees to participate in this study, the following will occur:
- The study team member will guide the participant to open the study smartphone app on their phone.
- The app will provide a tutorial on how to take a measurement, after which the participant will complete their first measurement. The Duke research team member will assist the participant to ensure it is taken correctly. The measurement involves taking a video of the participant's fingertip using the app by placing their finger on the smartphone camera and holding their hand flat on a table. The video frames are immediately processed in real-time to extract the blood flow signal. The app automatically uploads the blood flow signal to the Measure Labs cloud backend.
- Once the patient has completed their first measurement, they will be considered enrolled in the study.
- Study team will measure participant's vital signs (heart rate, respiratory rate, blood pressure, temperature, and oxygen saturation) after they have been enrolled into the study.
- A digital thermometer will be sent home with the participants on day of discharge. The app will provide an input for the participant to enter their daily temperature.
Throughout the study, the participant will be expected to place their fingertip on their smartphone camera twice a day and take their temperature once a day. Participants will receive two text messages with a link to enter their temperature, scan their fingertip with their camera, and answer some questions about their current health status. Participation will occur from day of consent to 30 days after patient was enrolled. During the final week of the study, the patient will be asked if they would like to continue receiving text messages for an additional 60 days. If they decline or don't respond, after day 30, participant will no longer receive text messages.
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned readmissions
Number of unplanned readmissions in 30 days
Measured: From discharge date to 30, 60, 90 days post discharge
Secondary outcomes (2)
All cause mortality
Rate of mortality for any reason for 30 days after discharge
Measured: Date of discharge to 30, 60, 90 days post discharge
Emergency Department Visits
Number of emergency department visits after discharge
Measured: Date of discharge to 30, 60, 90 days post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start26 Oct 2023
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (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.
- 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Measure Labs, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Responsible party
- Sponsor
- Investigators
- Lana Wahid, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099756
- Sponsor's protocol ID
- DReAMS-2
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discharge Readmission Analysis and Management in Sepsis (DReAMS-2): Augmenting Readmission Risk Models With Smartphone PPG Signals and Deep Learning, an Adaptive Platform
- ClinicalTrials.gov ID
- NCT06099756
- Acronym / sponsor ID
- DReAMS-2
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Measure Labs, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke University
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 25 Oct 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.
This is an adaptive platform. This study is being done to collect information that will help us identify trends in patients with sepsis and other health conditions being readmitted into hospitals within 30 days of being discharged. This information will be used to create a computer tool that will help predict a patient's risk of being readmitted into the hospital after being discharged.
Participants will allow the study team to follow their health after they are discharged by taking their temperature once a day and placing their index finger over their smartphone camera when prompted by a text message. Participants will receive the text messages twice a day. When the participant receives the text message, they will click on the link and follow the instructions. Instructions include how to long to keep your finger on your phone camera and how to report your daily temperature. Additional questions will also be asked. After 30 days, the text messages will stop, and participation will be complete.
Detailed description
Patients admitted into the hospital for sepsis and other health conditions (see inclusion criteria) and planning to be discharged within 72 hours will be approached for this study. Once patient agrees to participate in this study, the following will occur:
- The study team member will guide the participant to open the study smartphone app on their phone.
- The app will provide a tutorial on how to take a measurement, after which the participant will complete their first measurement. The Duke research team member will assist the participant to ensure it is taken correctly. The measurement involves taking a video of the participant's fingertip using the app by placing their finger on the smartphone camera and holding their hand flat on a table. The video frames are immediately processed in real-time to extract the blood flow signal. The app automatically uploads the blood flow signal to the Measure Labs cloud backend.
- Once the patient has completed their first measurement, they will be considered enrolled in the study.
- Study team will measure participant's vital signs (heart rate, respiratory rate, blood pressure, temperature, and oxygen saturation) after they have been enrolled into the study.
- A digital thermometer will be sent home with the participants on day of discharge. The app will provide an input for the participant to enter their daily temperature.
Throughout the study, the participant will be expected to place their fingertip on their smartphone camera twice a day and take their temperature once a day. Participants will receive two text messages with a link to enter their temperature, scan their fingertip with their camera, and answer some questions about their current health status. Participation will occur from day of consent to 30 days after patient was enrolled. During the final week of the study, the patient will be asked if they would like to continue receiving text messages for an additional 60 days. If they decline or don't respond, after day 30, participant will no longer receive text messages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized adults who have been diagnosed to include but not limited to sepsis and heart failure.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Admitted to the hospital for 48 hours or greater
- Admitted with an index diagnoses of sepsis. We defined sepsis based on the 2018 Centers for Disease Control and Prevention's Adult Sepsis Event (ASE).
- [1] A subject must have an order for blood cultures, at least 4 qualifying antimicrobial days AND Evidence of at least 1 end organ dysfunction (new vasopressors, initiation of mechanical ventilation, doubling of serum creatinine (or GFR reduction by 50%), total bilirubin ≥ 2.0 mg/dl, an increase by 100% from baseline, platelet count < 100 cells/ul, and lactate ≥ 2.0.
- The adaptive design will allow the expansion into additional index hospitalization diagnosis (for example, heart failure exacerbation, sickle cell crises, COPD exacerbation, hip fractures, pneumonia, post surgical patients, diabetes mellitus)
Key exclusion criteria (12 listed)
- Imminent death or anticipated death during index admission (to include comfort care or hospice)
- Patients due to be transferred to another acute care facility
- Participants not proficient with written and spoken English.
- Participants who do not have a smartphone and valid mobile number to receive text messages.
- Participants leaving the hospital against medical advice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unplanned readmissions
Time frame: From discharge date to 30, 60, 90 days post discharge
Number of unplanned readmissions in 30 days
2 secondary outcomes
All cause mortality
Time frame: Date of discharge to 30, 60, 90 days post discharge
Emergency Department Visits
Time frame: Date of discharge to 30, 60, 90 days post discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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. This study is not recruiting at the moment.
Lana Wahid, MD principal investigator
Duke University
3 sites 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 Measure Labs, Inc. at 3 sites 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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lana Wahid, MD (919-684-5670, lana.wahid@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned readmissions (time frame: From discharge date to 30, 60, 90 days post discharge). 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 7 Nov 2023.