Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/07/2006
Date assigned
08/08/2006
Last edited
25/04/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jon Shaffer

ORCID ID

Contact details

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

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 measures

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

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

http://www.fresenius-kabi.com

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22796064

Publication citations

  1. 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.

Additional files

Editorial Notes