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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT01713257
Eligibility Criteria:
Inclusion Criteria:
1. ICU patients requiring mechanical ventilation or APACHE II score equal or more than 10
2. Patients arrived at ICU within 24 hours before feeding
3. Anticipated tube feeding for at least 5 days
4. Age of 18 years and older
Exclusion Criteria:
1. Inability to be fed via the gastrointestinal tract
2. Allergic to whey protein isolate (WPI), soy protein isolate, glutamine, fish oil or any components in study formulas
3. Hemodynamically unstable, requiring significant dose of vasopressor or inotropes infusion (Dopamine or dobutamine \> 5 microgram/kg/min or noradrenaline \> 0.1 microgram/kg/min)
4. Known insulin dependent diabetes mellitus
5. Cerebral hemorrhage or severe head injury (Glasgow Coma Scale Score ≤ 8)
6. Active bleeding requiring ongoing blood transfusion
7. Platelet count \< 30,000/mm3 or INR \> 5
8. Pre-existing incurable disease (uncontrolled cancer, terminal disease, patient's legal representative not committed to full support)
9. On chemotherapy, radiation therapy within the previous 6 months or immunosuppressive regimen (including prednisolone or aspirin at least 7 days consecutively within the previous 4 weeks) or on other investigational drugs
10. Any genetic immune or autoimmune disorder; known HIV-positive patients
11. Severe chronic liver disease (Child- Pugh score of 11-15)
12. Renal failure requiring renal replacement therapy
13. Pregnancy or lactation
14. Unable to obtain inform consent from patient or his/her legal representative
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01713257
Study Brief:
Protocol Section:
NCT01713257