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 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
NCT ID:
NCT04475666
Eligibility Criteria:
Inclusion Criteria(on ICU calendar day 4 or the morning of day 5)
1. Age ≥18-years old
2. Patient started on enteral nutrition (EN) via nasogastric/orogastric or duodenal or percutaneous endoscopic gastrostomy (PEG) or jejunostomy tubes.
3. The patient is on invasive mechanical ventilation and unlikely to be discharged from ICU next day.
Exclusion Criteria:
1. Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
2. Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
3. Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
4. Patients being fed entirely through oral route - i.e. those who are eating.
5. Pregnancy.
6. Burn patients.
7. Prisoners or those undergoing forced treatment.
8. Patients with hepatic encephalopathy or Child C liver cirrhosis
9. Inherited defect of amino acid metabolism.
10. Allergies to protein supplement
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04475666
Study Brief:
Protocol Section:
NCT04475666