Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Parenteral Nutrition Clinical Trial

Official title:

A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451646
• Other study ID #: 05-SMOF-006
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2007
• Last updated: August 26, 2010
• Start date: October 2007
• Est. completion date: November 2008

Study information

• Verified date: October 2008
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationDenmark: Ministry of HealthFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Israel: Ministry of HealthNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks

• Written consent from the subject

Exclusion Criteria:

• Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients

• Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia

• Severe liver insufficiency

• Severe blood coagulation disorders

• Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy

• General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration

• Unstable conditions

• Unstable angina pectoris

• Acute shock

• Chemotherapy within 4 weeks before start of the trial

• Chemotherapy during the trial

• Subjects for whom the trial treatment is not appropriate

• Female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum pregnancy test and must agree to maintain adequate birth control practice during the study.

• Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study

• Prior inclusion in the present study

• Any other feature that in the opinion of the investigator should preclude study participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

Drug:
• SMOF lipid and Intralipid
1-2 g, 5-7 days, 28 days

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Melbourne	Victoria
Australia	North Shore Private Hospital	Saint Leonards	New South Wales
Denmark	Aalborg University Hospital, Department of Medical Gastroenterology	Aalborg
Denmark	Rigshospitalet, Department of Medical Gastroenterology	Copenhagen
France	Hopital Beaujon	Clichy la Garenne
France	Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon	Lyon
Israel	Beilinson Medical Center, Department of Surgery "B"	Petah Tiqwa
Netherlands	University Medical Center	Nijmegen
Poland	Wydzial Lekarski I Katedra Chirurgii Ogolnej	Krakow
Poland	Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orlowskiego	Warsaw
United Kingdom	Hope Hospital	Manchester
United Kingdom	University Hospital, Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi

Countries where clinical trial is conducted

Australia,  Denmark,  France,  Israel,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables		day 0, week 2, week 4	No