A Study to Compare the Occurrence of Elevated Liver Enzymes Between Adult Patients Receiving Daily IV Fat Emulsions versus Only Three Times per Week
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-001177
Sponsor Protocol Number: 15-001177
About this study
The purpose of this study is to compare the incidence and frequency of elevated liver enzymes or parenteral (IV) nutrition-associated liver disease, in adult patients who are receiving daily versus three time per week soybean based intravenus (IV) fat emulsions.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Age 18 to 75 years old inclusive, at initiation of Home Parenteral Nutrition
- Able to provide informed consent
- Anticipated duration of HPN greater than 3 months
- Not previously on HPN at Mayo Clinic or elsewhere
- Agree to be managed by the Mayo HPN program
- No history of alcohol addiction
- No known liver disease (as determined by review of EMR)
Exclusion Criteria
- Pregnant women
- Failure to provide consent
- On HPN for less than three months
- Has previous proven addiction and dependence to alcohol and/or heavy alcohol consumption reported (during history or reported in the EMR)
- Documented liver disease
- Will not be managed by the Mayo Clinic HPN team
- Has active infection (as determined by the clinician) at the initiation of HPN
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ryan Hurt, M.D., Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available