Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Lipid Emulsions and Liver Function - Results After 5 Years.

Lead Sponsor:

Stanley Dudrick's Memorial Hospital

Conditions:

Liver Failure

Parenteral Nutrition-Related Hepatitis

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

Brief Summary

Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). Th...

Detailed Description

Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). De...

Eligibility Criteria

Inclusion

  • ≥ 18 years of age,
  • chronic intestinal failure on PN including lipids,
  • metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
  • ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN

Exclusion

  • preexisting liver dysfunction (an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 3 times x normal value),
  • patients with a history of cancer and anti-cancer treatment within the last 5 years,
  • severe hyperlipidemia,
  • severe coagulopathy,
  • severe renal insufficiency,
  • acute thromboembolic events,
  • positive test for HIV, Hepatitis B or C (from medical history),
  • known or suspected drug or alcohol abuse,
  • participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial,
  • for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.

Key Trial Info

Start Date :

January 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2020

Estimated Enrollment :

65 Patients enrolled

Trial Details

Trial ID

NCT04347902

Start Date

January 1 2016

End Date

April 1 2020

Last Update

April 17 2020

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Stanley Dudrick's Memorial Hospital

Skawina, Poland, 32-050