Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

The aim of this study is to evaluate the safety and tolerance of SMOFlipid 20% in comparison to a standard lipid emulsion Intralipid 20% in patients requiring long-term parenteral nutrition. The safety and tolerance will be evaluated by biochemistry, hematology and coagulation variables, vital signs and adverse events. Further objectives to evaluate are the influence of SMOFlipid 20% on inflammation processes, the efficacy of anti-oxidative properties of vitamin E supplemented to SMOFlipid 20%, and the fatty acid pattern in red blood cells and serum.

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Key information

Conditions

Parenteral Nutrition Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

North Shore Private Hospital, Saint Leonards, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

In- and out-patients in need of parenteral nutrition due to inability to sustain an adequate oral/enteral food intake for at least 4 weeks
Written consent from the subject

Exclusion criteria

Known hypersensitivity to fish-, egg-, soy-, or peanut-protein or to any of the active substances or excipients
Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia
Severe liver insufficiency
Severe blood coagulation disorders
Subjects with chronic stable renal insufficiency defined as S-creatinine value of > 25 mg/l (200 µmol/l) or receiving dialysis/hemofiltration therapy
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration
Unstable conditions
Unstable angina pectoris
Acute shock
Chemotherapy within 4 weeks before start of the trial
Chemotherapy during the trial
Subjects for whom the trial treatment is not appropriate
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.
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
Prior inclusion in the present study
Any other feature that in the opinion of the investigator should preclude study participation

Treatment and study plan

SMOF lipid and Intralipid

Drug

1-2 g, 5-7 days, 28 days

Primary outcomes

Safety and tolerability of SMOFlipid 20% assessed by laboratory and clinical parameters (biochemistry, hematology, coagulation), vital signs, adverse events (AEs) as well as inflammation and lipid peroxidation variables

Time frame: day 0, week 2, week 4

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Registry information

Official study title

A Double-blind, Randomised Study Comparing the Safety and Tolerance of SMOFlipid 20% in Long-term Treatment With Parenteral Nutrition

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Mar 23, 2007
Registry last updated: Aug 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed