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 @ 4:24 PM
Ignite Modification Date:
2025-12-24 @ 4:24 PM
NCT ID:
NCT05839366
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18;
* A patient diagnosed with septic shock;
* It needs to be treated with analgesics, sedatives, and vasopressors for a period of not less than 48 hours;
* Mechanical ventilation by the ventilator is needed;
* Obtain the informed consent of the human subjects or their legal representatives;
Exclusion Criteria:
* Currently pregnant or breastfeeding;
* Confirmed acute severe intracranial or spinal neurologic diseases caused by vascular, intracranial expansion, or injury;
* History of uncontrolled or malignant hypertension (sustained (\>3 hours) heart rate \>150 beats/min or systolic blood pressure \>180 mmHg); recent history of ketamine use；
* Hearing or vision loss, or any other conditions likely to severely interfere with the collection of research data;
* Long-term use of benzodiazepines or opioids;
* Known allergy to any investigational drug;
* Subject receiving sedative therapy not for tolerance to mechanical ventilation (e.g., seizures);
* Unlikely to require ongoing sedation during mechanical ventilation (e.g., Guillain-Barré syndrome);
* Patients deemed unlikely by the attending physician to be weaned from mechanical ventilation, such as those with diseases/injuries primarily affecting respiratory neuromuscular function and conditions requiring prolonged ventilatory support, which are clearly irreversible (e.g., high spinal cord injury);
* Open eye injury or other ophthalmic diseases;
* Concurrent participation in any other interventional study (any study assigning subjects to different treatment groups and/or conducting unconventional diagnostic or monitoring procedures).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05839366
Study Brief:
Protocol Section:
NCT05839366