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

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

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.

Study Overview

• Status: Completed
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Drug: SMOF lipid and Intralipid

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Saint Leonards, New South Wales, Australia, 2065
      • North Shore Private Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
• Denmark
  • Aalborg, Denmark, 0 9000
    • Aalborg University Hospital, Department of Medical Gastroenterology
  • Copenhagen, Denmark, 0 2100
    • Rigshospitalet, Department of Medical Gastroenterology
• France
  • Clichy la Garenne, France, 92110
    • Hopital Beaujon
  • Lyon, France, 69437
    • Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon
• Israel
  • Petah Tiqwa, Israel, 0 45100
    • Beilinson Medical Center, Department of Surgery "B"
• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • University Medical Center
• Poland
  • Krakow, Poland, 31-501
    • Wydzial Lekarski I Katedra Chirurgii Ogolnej
  • Warsaw, Poland, 00-416
    • Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego
• United Kingdom
  • Manchester, United Kingdom, 0M6 8HD
    • Hope Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • University Hospital, Queen's Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; SMOFlipid	Drug: SMOF lipid and Intralipid; 1-2 g, 5-7 days, 28 days
Active Comparator: 2; Intralipid	Drug: SMOF lipid and Intralipid; 1-2 g, 5-7 days, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fresenius Kabi
• Investigators: Principal Investigator: Jon Shaffer, MD, Hope Hospital, Manchester, United Kingdom

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: March 22, 2007
• First Submitted That Met QC Criteria: March 22, 2007
• First Posted (Estimate): March 23, 2007

Study Record Updates

• Last Update Posted (Estimate): August 27, 2010
• Last Update Submitted That Met QC Criteria: August 26, 2010
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous; Soybean oil, phospholipid emulsion
• Other Study ID Numbers: 05-SMOF-006