Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT06099756
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06099756
Study Brief:
Protocol Section:
NCT06099756