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 @ 12:54 AM
Ignite Modification Date:
2025-12-25 @ 12:54 AM
NCT ID:
NCT06225167
Eligibility Criteria:
Inclusion Criteria:
* Patients ≥18 years ICU location status
Exclusion Criteria:
* If patient has one of the following:
* Coagulopathy (defined as: platelets \< 50,000/µL, international normalized ratio(INR) \> 1.5, or partial thromboplastin time \> 2 times the control value)
* Mechanical ventilation for \> 48 hours and on \< 50% goal tube feeds
* Shock state on vasopressors/inotropes and on \< 50% goal tube feeds (or \< 50% of diet)
* On total parenteral nutrition
* Use of acid suppressive therapy prior to admission
* Admission with GI bleeding
* History of peptic ulcer disease
* Surgery on the GI tract or cardiac surgery during the current hospital admission
* Pregnancy
* H. pylori infection treatment
* Hypersecretory disorder (ex: Zollinger-Ellison)
* Known erosive esophagitis/gastritis (not heartburn or gastroesophageal reflux disease)
* Traumatic brain injury with Glasgow Coma Scale score ≤ 10
* Major burn (˃30% body surface area)
* Major trauma requiring ICU admission
* Spinal cord injury requiring ICU admission
If patient has two or more of the following:
* Administration of ˃ 100 mg daily of prednisolone (or equivalent)
* Sepsis
* Acute renal failure
* Acute hepatic failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06225167
Study Brief:
Protocol Section:
NCT06225167