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 @ 2:59 AM
Ignite Modification Date:
2025-12-25 @ 2:59 AM
NCT ID:
NCT02796833
Eligibility Criteria:
Inclusion Criteria:
* Signed and dated informed consent form (ICF) to participate before any study related procedures are performed
* Adult over the age of 18
* Both males and females
* Clinically stable for at least 4 weeks with no acute medical co-morbidities
* Patients on a stable Intralipid HPN regimen for 6 months and expected to require long-term PN for at least 13 more months
Exclusion Criteria:
Subjects not already on Intralipid PN Inability to give informed consent Alcohol or drug abuse Pregnant and lactating women
Clinical instability such as the following:
* Acute pulmonary edema
* Decompensated heart failure
* Decompensated chronic liver disease
* Severe post-traumatic conditions
* Uncontrolled diabetes mellitus
* Acute myocardial infarction
* Acute stroke
* Acute thromboembolism
* Metabolic acidosis
* Sepsis
* Hypotonic dehydration
* Coagulopathy with prolonged aPTT or INR Elevated triglyceride level: more than 4.5 mmol/L Active malignancy with life expectancy less than one year Subjects who are hypersensitive or allergic to the product ingredients of SMOF or Intralipid, including soybean oil, peanuts, fish oil, and egg as well as allergy to peanuts.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02796833
Study Brief:
Protocol Section:
NCT02796833