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Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

NCT ID: NCT00885781

Last Updated: 2011-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-12-31

Brief Summary

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Comparison of efficacy and safety of two lipid emulsion products will be performed on gastrectomy patients postsurgically.

Detailed Description

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The comparison of two lipid emulsion product will be performed. Patients who plan to accept gastrectomy will be consider for trial and signed content will be obtained. If the patient needs total parenteral nutrition (TPN) treatment after surgery for at least 5 days and meets all criteria, then he/she will be enrolled and randomized to ether of the groups, SMOFlipid or Lipovenoes MCT. During the treatment period, efficacy variables and safety variables will be measured. Life quality evaluation will also be performed through questionnaires collection.

Conditions

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Gastrectomy Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SMOFlipid

Group Type EXPERIMENTAL

lipid emulsion for TPN

Intervention Type DRUG

1-2 g lipid emulsion /kgBW-day, for consecutive 5 days

Lipovenoes MCT

Group Type ACTIVE_COMPARATOR

lipid emulsion for TPN

Intervention Type DRUG

1-2 g lipid emulsion /kgBW-day, for consecutive 5 days

Interventions

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lipid emulsion for TPN

1-2 g lipid emulsion /kgBW-day, for consecutive 5 days

Intervention Type DRUG

Other Intervention Names

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SMOFlipid 20%

Eligibility Criteria

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Inclusion Criteria

1. Age between 25 \~ 75 years old
2. Postoperative (gastrectomy) patients required parental nutrition for at least 5 days
3. Signed informed consent form

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 \>2.26 mmol/l (\>200 mg/dl) the subject must not be included
3. Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
4. Severe renal insufficiency with need for dialysis, chronic stable renal insufficiency defined as S-creatinine value of \>3mg/dL (250 µmol/l), or dialysis/hemofiltration therapy
5. Over weight (BMI\> 30kg/m2)
6. Severe blood coagulation disorders
7. Inborn abnormality in amino acid metabolism
8. Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
9. Known diabetic ketoacidosis 7 days prior to randomization.
10. Acute shock
11. General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
12. Pregnancy or lactation
13. Chemotherapy within 7 days before start of the trial
14. Participation in another clinical study with an investigational drug or an investigational medical device within 1 month prior to start of study or during the study
15. Already accept parental nutrition therapy.
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming-Tsan Lin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chief of General Suery department

Locations

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National Taiwan University Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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SMOF-002-I P4

Identifier Type: -

Identifier Source: secondary_id

200803090M

Identifier Type: -

Identifier Source: org_study_id