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 |
| Secondary identifying numbers | Protocol No.: 05-SMOF-006 |
- 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
Scientific
Consultant Gastroenterologist
H2 Teaching Block
Hope Hospital
Salford
Manchester
M6 8HD
United Kingdom
Study information
| Study design | Multi-national, multi-centre, randomised, active-controlled, double-blind, parallel study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 15/10/2007 |
| Completion date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 48 patients per protocol |
| 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
- Australia
- Denmark
- England
- France
- Israel
- Netherlands
- Poland
- United Kingdom
Study participating centre
Consultant Gastroenterologist
Manchester
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
Fresenius Kabi Deutschland GmbH (Germany)
Industry
Industry
Kabi Strategic Business Center
Preclinical & Clinical Development Pharma
Else-Kröner-Str. 1
Bad Homburg
61352
Germany
| Phone | +49 (0)6172 686 7295 |
|---|---|
| ingrid.mueller@fresenius-kabi.com | |
| Website | http://www.fresenius-kabi.com |
"ROR" |
https://ror.org/01v376g59 |
Funders
Funder type
Industry
Fresenius Kabi Deutschland GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
