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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT03098459
Eligibility Criteria:
Inclusion Criteria:
• Adult trauma and/or burn patients, injury from any mechanism, requiring admission to an Adult ICU for the treatment of shock (any type), respiratory failure, and/or neurologic failure, including monitoring for deteriorating brain function.
Exclusion Criteria:
* Inability to obtain informed consent within the 72 hours following injury
* Attending physician refusal
* Patient and/or surrogate refusal
* 72-hour period of eligibility was exceeded before the patient was screened
* Patient unable to consent and no surrogate available within the 72-hour period
* Residence \> 200 miles from study site and do not regularly visit the Nashville area.
* Patients who are homeless and have no secondary contact person available.
* Severe prior cognitive or neurodegenerative disorder that prevents a patient from living independently at baseline
* Inability to understand English or Spanish or bilateral deafness or bilateral vision loss
* Inability to co-enroll with other studies
* Prisoners
* Substance abuse requiring treatment, known psychotic disorder (e.g., schizophrenia or schizoaffective disorder), or recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
* Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of screening).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03098459
Study Brief:
Protocol Section:
NCT03098459