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

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00451646
First received: March 22, 2007
Last updated: August 26, 2010
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Parenteral Nutrition
Drug: SMOF lipid and Intralipid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • 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 [ Time Frame: day 0, week 2, week 4 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451646

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

No publications provided

Responsible Party: Dr. Ingrid Mueller, Fresenius Kabi Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00451646     History of Changes
Other Study ID Numbers: 05-SMOF-006
Study First Received: March 22, 2007
Last Updated: August 26, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: The Ministry of the Interior and Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Ministry of Health

ClinicalTrials.gov processed this record on July 23, 2014