Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol No.: 05-SMOF-006
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics Committee (EC) approval in all countries, except Australia as of 9th October 2007
Study design
Multi-national, multi-centre, randomised, active-controlled, double-blind, parallel study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
SMOFlipid 20% and Intralipid 20%
Primary outcome measure
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.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
15/10/2007
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48 patients per protocol
Participant 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
Recruitment start date
15/10/2007
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Australia, Denmark, France, Israel, Netherlands, Poland, United Kingdom
Trial participating centre
Consultant Gastroenterologist
Manchester
M6 8HD
United Kingdom
Sponsor information
Organisation
Fresenius Kabi Deutschland GmbH (Germany)
Sponsor details
Kabi Strategic Business Center
Preclinical & Clinical Development Pharma
Else-Kröner-Str. 1
Bad Homburg
61352
Germany
+49 (0)6172 686 7295
ingrid.mueller@fresenius-kabi.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Fresenius Kabi Deutschland GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22796064
Publication citations
-
Results
Klek S, Chambrier C, Singer P, Rubin M, Bowling T, Staun M, Joly F, Rasmussen H, Strauss BJ, Wanten G, Smith R, Abraham A, Szczepanek K, Shaffer J, Four-week parenteral nutrition using a third generation lipid emulsion (SMOFlipid)--a double-blind, randomised, multicentre study in adults., Clin Nutr, 2013, 32, 2, 224-231, doi: 10.1016/j.clnu.2012.06.011.