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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00451646




Registration number
NCT00451646
Ethics application status
Date submitted
22/03/2007
Date registered
23/03/2007
Date last updated
27/08/2010

Titles & IDs
Public title
Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Scientific title
A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition
Secondary ID [1] 0 0
05-SMOF-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenteral Nutrition 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SMOF lipid and Intralipid

Experimental: 1 - SMOFlipid

Active Comparator: 2 - Intralipid


Treatment: Drugs: SMOF lipid and Intralipid
1-2 g, 5-7 days, 28 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
day 0, week 2, week 4

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
North Shore Private Hospital - Saint Leonards
Recruitment hospital [2] 0 0
Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
3168 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
France
State/province [3] 0 0
Clichy la Garenne
Country [4] 0 0
France
State/province [4] 0 0
Lyon
Country [5] 0 0
Israel
State/province [5] 0 0
Petah Tiqwa
Country [6] 0 0
Netherlands
State/province [6] 0 0
Nijmegen
Country [7] 0 0
Poland
State/province [7] 0 0
Krakow
Country [8] 0 0
Poland
State/province [8] 0 0
Warsaw
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Manchester
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fresenius Kabi
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00451646
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jon Shaffer, MD
Address 0 0
Hope Hospital, Manchester, United Kingdom
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00451646