A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSIO

Phase 4

Completed

• Conditions: chronic bowel failure; chronic intestinal failure; 10025477

• Registration Number: NL-OMON55393
• Lead Sponsor: B.Braun Melsungen AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Signed informed consent available
2. Male or female patients >= 18 years of age
3. Patients with chronic intestinal failure receiving HPN including lipids in
whom
the parenteral macronutrients have not been changed by more than 10% for
at least 3 months
4. Patients receiving >= 3.0 g lipids/kg body weight per week

Exclusion Criteria

1. Persistent high total bilirubin values in medical history of the last 6
months
(> 40µmol/l)
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
2 years
4. Hypersensitivity to egg, fish or soya-bean protein or to any of the active
substances or excipients
5. Patients treated in the past or currently with Teduglutide
6. Contraindications to investigational products (if available from medical
records) including:
- Severe hyperlipidemia, including severe hypertriglyceridaemia (>= 1000
mg/dl or 11.4 mmol/l)
- Severe coagulopathy
- Intrahepatic cholestasis
- Severe hepatic insufficiency
- Severe renal insufficiency in absence of renal replacement therapy
- Acute thromboembolic events
- Fat embolism
- Aggravating haemorrhagic diatheses
- Metabolic acidosis
7. General contraindications to parenteral nutrition (if available from medical
records) including:
- Unstable circulatory status with vital threat (states of collapse and shock)
- Acute phase of cardiac infarction or stroke
- Unstable metabolic conditions (e.g. decompensated diabetes mellitus,
severe sepsis, coma of unknown origin)
- Inadequate cellular oxygen supply
- Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and
hypotonic dehydration)
- Acute pulmonary edema
- Decompensated cardiac insufficiency
8. Positive test for HIV, Hepatitis B or C (from medical history)
9. Known or suspected drug or alcohol abuse
10. Patients who are unwilling or mentally and/or physically unable to adhere to
study procedures
11. Participation in another interventional clinical trial in parallel or
within three
months prior to the start of this clinical trial
12. Any medical condition that in the opinion of the investigator might put the
subject at risk or interfere with patients participation
For women with childbearing potential (i.e. females who are not chemically or
surgically sterile or females who are not post-menopausal)
13. Women of childbearing potential tested positive on standard pregnancy test
(urine dipstick)
14. Lactation
15. Women of childbearing potential who do not agree to apply adequate
contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the change of liver function parameters<br /><br>defined as the sum of the N(0,1)-transformed differences in<br /><br>bilirubin, Alanine transaminase (ALT) and Aspartate transaminase (AST) from<br /><br>baseline to visit 2.</p><br>