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:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-25 @ 12:58 AM
NCT ID:
NCT04312893
Eligibility Criteria:
Inclusion Criteria:
* Age 20-90
* Apache score \<30
* Patients admitted in the ICU
* Positive delirium score as: 4 or more points according to the Intensive Care Delirium Screening Checklist (ICDSC)
* Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4 -1, -2
Exclusion Criteria:
* Coagulopathy: Prolong Prothrombin Time (PPT) activated Partial Thromboplastin Time (aPTT) more than 4 times
* Thrombocytopenia - low platelet count
* Clinically unstable: receiving two inotropic agents or Fraction of Inspired Oxygen (FiO2) \>70%
* Rass score: 0, -3, -4 (at the time of enrollment)
* Primary central nervous system disorder: stroke, traumatic brain injury, central nervous system infections, brain tumors, recent intracranial surgery
* Alcohol or substance withdrawal.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
90 Years
Study:
NCT04312893
Study Brief:
Protocol Section:
NCT04312893