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:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2025-12-26 @ 5:18 PM
NCT ID:
NCT04075006
Eligibility Criteria:
Inclusion Criteria:
1. Adult ICU (Medical or surgical) patients (\> 14 years old)
2. Mechanically ventilated within the previous 24 hours and expected to remain intubated for more than 24 hours.
3. The patient requires ongoing sedative medication
4. No objection from the ICU attending MD for enrollment
Exclusion Criteria:
1. Patients with a history of dementia or psychiatric disorders or on any anti-psychotics or anti-depressants medications at home
2. Pregnancy
3. Age \< 14 years old
4. Expected to need mechanical ventilation less than 24 hours
5. Known hypersensitivity to ketamine
6. Patient on dexmedetomidine as primary sedative agent prior to randomization
7. Patients with cardiogenic shock, heart failure, myocardial infarction
8. History of end-stage liver disease.
9. Proven or suspected primary neurological injury (traumatic brain injury, ischemic stroke, intracranial hemorrhage, spinal cord injury, anoxic brain injury)
10. Patients with persistent heart rate (HR) \> 150 bpm or systolic blood pressure (SBP) \>180 mmHg
11. Patients who assigned as do-not-resuscitate order (DNR) or expected to die within 24 hours
12. Patients on ECMO
13. Patients with status epilepticus patients who are receiving the ketamine infusion for refractory status epilepticus
14. Proven or suspected status asthmaticus
15. Patients with expected targeted RASS of -5 such as patients on continuous infusion neuromuscular blockade
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT04075006
Study Brief:
Protocol Section:
NCT04075006