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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT01934595
Eligibility Criteria:
Inclusion Criteria:
* • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.
Exclusion Criteria:
* • Patients who cannot tolerate enteral nutrition
* Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract
* Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.
* Patients with refractory hypotension unresponsive to vasoactive medications
* Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)
* Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.
* Patients with end stage liver disease or undergoing liver transplant or liver resection surgery
* Patients whose physician thinks he/she should not participate
* Prisoners
* Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01934595
Study Brief:
Protocol Section:
NCT01934595