Status:
UNKNOWN
Discharge Readmission Analysis and Management in Sepsis (DReAMS-2)
Lead Sponsor:
Measure Labs, Inc.
Collaborating Sponsors:
Duke University
Conditions:
Sepsis
Eligibility:
All Genders
18-100 years
Brief 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 with...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
October 26 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06099756
Start Date
October 26 2023
End Date
October 1 2024
Last Update
November 7 2023
Active Locations (3)
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1
Duke Regional Hospital
Durham, North Carolina, United States, 27704
2
Duke University Hospital
Durham, North Carolina, United States, 27710
3
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609