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08 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public title | A double-blind, randomised study comparing the safety and tolerance of SMOFlipid 20% and Intralipid 20% in long-term treatment with parenteral nutrition |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | Protocol No.: 05-SMOF-006 |
| 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). |
| Lay summary | |
| 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 |
| Countries of recruitment | Australia, Denmark, France, Israel, Netherlands, Poland, United Kingdom |
| Disease/condition/study domain | Parenteral nutrition/malnutrition |
| Participants - 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 |
| Participants - 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262.5 mg/dl) the subject must be withdrawn 3.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 |
| Anticipated start date | 15/10/2007 |
| Anticipated end date | 31/12/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 48 patients per protocol |
| Interventions |
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 |
| 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. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Fresenius Kabi Deutschland GmbH (Germany) |
| Trial website | |
| Publications | |
| Contact name | Dr Jon Shaffer |
| Address |
Consultant Gastroenterologist
H2 Teaching Block Hope Hospital Salford |
| City/town | Manchester |
| Zip/Postcode | M6 8HD |
| Country | United Kingdom |
| Sponsor | Fresenius Kabi Deutschland GmbH (Germany) |
| Address |
Kabi Strategic Business Center
Preclinical & Clinical Development Pharma Else-Kröner-Str. 1 |
| City/town | Bad Homburg |
| Zip/Postcode | 61352 |
| Country | Germany |
| Tel | +49 (0)6172 686 7295 |
| Fax | +49 (0)6172 686 8749 |
| ingrid.mueller@fresenius-kabi.com | |
| Sponsor website: | http://www.fresenius-kabi.com |
| Date applied | 11/07/2006 |
| Last edited | 21/04/2011 |
| Date ISRCTN assigned | 08/08/2006 |
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| © 2012 ISRCTN unless otherwise stated. | |
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