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

NCT00451646 | Completed Phase 3

• 1 other identifier: 05-SMOF-006
• Study Type: interventional
• Target: 75
• Locations: 7 countries
• Sites: 12

Brief Summary

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.

Conditions

Parenteral Nutrition

Outcome Measures

Primary Outcomes (1)

• 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

  day 0, week 2, week 4

Study Arms (2)

1

EXPERIMENTAL

SMOFlipid

Drug: SMOF lipid and Intralipid

2

ACTIVE COMPARATOR

Intralipid

Drug: SMOF lipid and Intralipid

Interventions

SMOF lipid and Intralipid DRUG

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

1; 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Any other feature that in the opinion of the investigator should preclude study participation

Sponsors & Collaborators

• Fresenius Kabi: lead

Study Sites (12)

North Shore Private Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Aalborg University Hospital, Department of Medical Gastroenterology

Aalborg, 0 9000, Denmark

Location

Rigshospitalet, Department of Medical Gastroenterology

Copenhagen, 0 2100, Denmark

Location

Hopital Beaujon

Clichy, 92110, France

Location

Hopital Edouard Herriot, Unite de Nutrition a Domicile Lyon

Lyon, 69437, France

Location

Beilinson Medical Center, Department of Surgery "B"

Petah Tikva, 0 45100, Israel

Location

University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Wydzial Lekarski I Katedra Chirurgii Ogolnej

Krakow, 31-501, Poland

Location

Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego

Warsaw, 00-416, Poland

Location

Hope Hospital

Manchester, 0M6 8HD, United Kingdom

Location

University Hospital, Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hyperphagia

Interventions

soybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Shaffer, MD

  Hope Hospital, Manchester, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 22, 2007
• First Posted: March 23, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2008
• Last Updated: August 27, 2010

Record last verified: 2008-10

Locations

AU (2); NL (1); IL (1); FR (2); PL (2); GB (2); DK (2)