Parenteral Lipid Emulsions and the Liver Function

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03044639
• Date of registration: 22/01/2017
• Prospective Registration: No
• Primary sponsor: Stanley Dudrick's Memorial Hospital
• Public title: Parenteral Lipid Emulsions and the Liver Function
• Scientific title: Four Parenteral Lipid Emulsions and the Liver Function
• Date of first enrolment: April 1, 2010
• Target sample size: 64
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03044639
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: Phase 4

Countries of recruitment

Poland

Contacts

• Name: Stanislaw Klek, MD PhD
• Affiliation: Stanley Dudrick's Memorial Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. chronic intestinal failure (CIF) receiving HPN including lipids

2. metabolic stability on HPN for more than three months (metabolic stability = the
absence of pathological laboratory resulting in the change of PN regime for at least
one month)

3. 1.0 g lipids/kg body weight per day as a part of PN

Exclusion Criteria:

1. Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline
phosphatase of more than 1.5 times x normal value

2. Patients in whom PN was interrupted for longer than 4 continuous weeks in the
preceding 6 months

3. Patients with history of cancer and anti-cancer treatment within the last 5 years

4. Severe hyperlipidemia

5. Severe coagulopathy

6. Severe renal insufficiency

7. Acute thromboembolic events

8. Positive test for HIV, Hepatitis B or C (from medical history)

9. Known or suspected drug or alcohol abuse

10. Participation in another interventional clinical trial in parallel or within three
months prior to the start of this clinical trial

11. 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Liver Failure

Intervention(s)

Drug: Lipid Emulsions, Intravenous

Primary Outcome(s)

Liver function [Time Frame: 12 months]

Secondary Outcome(s)

Liver function 3 [Time Frame: 12 months]

Liver function 4 [Time Frame: 12 months]

Liver function 5 [Time Frame: 12 months]

Liver function 2 [Time Frame: 12 months]

Secondary ID(s)

IVLE

Source(s) of Monetary Support

Please refer to primary and secondary sponsors