A double-blind, randomised study comparing the safety and tolerance of SMOFlipid 20% and Intralipid 20% in long-term treatment with parenteral nutrition

ISRCTN	ISRCTN39632561
DOI	https://doi.org/10.1186/ISRCTN39632561
Protocol serial number	Protocol No.: 05-SMOF-006
Sponsor	Fresenius Kabi Deutschland GmbH (Germany)
Funder	Fresenius Kabi Deutschland GmbH (Germany)

Submission date: 11/07/2006
Registration date: 08/08/2006
Last edited: 25/04/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jon Shaffer
Scientific

Consultant Gastroenterologist
H2 Teaching Block
Hope Hospital
Salford
Manchester
M6 8HD
United Kingdom

Study information

Primary study design	Interventional
Study design	Multi-national, multi-centre, randomised, active-controlled, double-blind, parallel study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To demonstrate the comparability in safety and tolerance between SMOFlipid 20% and Intralipid 20%. Please note that as of 9th October 2007, some changes were made to this record. The main changes were an update in ethics approval (previously no ethics information in the record), an update to the countries of recruitment (Germany dropped out and Poland joined) and an update to the anticipated start and end dates of the trial (these were moved forward).
Ethics approval(s)	Ethics Committee (EC) approval in all countries, except Australia as of 9th October 2007
Health condition(s) or problem(s) studied	Parenteral nutrition/malnutrition
Intervention	There were 48 patients per protocol from five European and two non-European countries. The interventions of this trial were the comparing of SMOFlipid 20% and Intralipid 20% on long-term treatment. Please note that as of 9th October 2007, the anticipated start and end dates of this trial were delayed. The previous start and end dates of this trial were: Original anticipated start date: 15/10/2006 Original anticipated end date: 31/12/2007
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	SMOFlipid 20% and Intralipid 20%
Primary outcome measure(s)	1. Laboratory variables: 1.1. Clinical chemistry parameters: triglycerides, total cholesterol AP, Aspartate Aminotransferase (AST - also known as S-GOT), gamma Glutamyl Transferase (g-GT), Alanine Aminotransferase (ALT - also known as S-GPT), sodium, potassium, chloride, magnesium, calcium, phosphate, total bilirubin, S-creatinine, urea, glucose, albumin, total protein, C-Reactive Protein 1.2. Haematology parameters: leucocytes, platelets, erythrocytes, haemoglobin, haematocrit, 1.3. Coagulation parameters: International Normalised Ratio (INR) 2. Adverse events 3. Vital signs: blood pressure (mmHg), heart rate (beats/min), body temperature (°C) 4. Lipid metabolism Rating of the safety and tolerance variables will be according to Common Terminology Criteria for Adverse Events.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	85 Years
Sex	All
Target sample size at registration	96
Key inclusion criteria	1. Male and female subjects between 18 and 85 years of age 2. In- or out-patients unable to sustain an adequate oral/enteral food intake for at least four weeks and need of parenteral nutrition 3. Written informed consent from the subject
Key exclusion criteria	1. Known hypersensitivity to fish, egg or soy protein or to any of the active substances or excipients 2. Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia. If the fasting S-triglyceride value at the time of inclusion is mopre than 3 mmol/l (>262.5 mg/dl) the subject must be withdrawn 3. Severe liver insufficiency 4. Severe blood coagulation disorders 5. Subjects with chronic stable renal insufficiency defined as S-creatinine value of more than 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy 6. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency 7. Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) 8. Unstable angina pectoris 9. Acute shock 10. Chemotherapy within four weeks before start of the trial 11. Chemotherapy during the trial 12. Subjects for whom the trial treatment (amounts, contents etc.) is not appropriate 13. 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 (e.g. hormonal contraceptives, contraceptive coil) 14. 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 15. Prior inclusion in the present study 16. Any other feature that in the opinion of the investigator should preclude study participation
Date of first enrolment	15/10/2007
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

United Kingdom
England
Australia
Denmark
France
Israel
Netherlands
Poland

Study participating centre

Consultant Gastroenterologist

Manchester
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2013		Yes	No