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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00451646
Recruitment Status : Completed
First Posted : March 23, 2007
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
Fresenius Kabi

Tracking Information
First Submitted Date  ICMJE March 22, 2007
First Posted Date  ICMJE March 23, 2007
Last Update Posted Date August 27, 2010
Study Start Date  ICMJE October 2007
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2007)
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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00451646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Official Title  ICMJE A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parenteral Nutrition
Intervention  ICMJE Drug: SMOF lipid and Intralipid
1-2 g, 5-7 days, 28 days
Study Arms  ICMJE
  • Experimental: 1
    SMOFlipid
    Intervention: Drug: SMOF lipid and Intralipid
  • Active Comparator: 2
    Intralipid
    Intervention: Drug: SMOF lipid and Intralipid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 24, 2008)
75
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   France,   Israel,   Netherlands,   Poland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00451646
Other Study ID Numbers  ICMJE 05-SMOF-006
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Ingrid Mueller, Fresenius Kabi Deutschland GmbH
Study Sponsor  ICMJE Fresenius Kabi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jon Shaffer, MD Hope Hospital, Manchester, United Kingdom
PRS Account Fresenius Kabi
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP