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Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

Primary Purpose

Gastrectomy, Malnutrition

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

lipid emulsion for TPN

About this trial

This is an interventional supportive care trial for Gastrectomy

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients
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
Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.)
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
Over weight (BMI> 30kg/m2)
Severe blood coagulation disorders
Inborn abnormality in amino acid metabolism
Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration)
Known diabetic ketoacidosis 7 days prior to randomization.
Acute shock
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
Pregnancy or lactation
Chemotherapy within 7 days before start of the trial
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
Already accept parental nutrition therapy.

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SMOFlipid

Lipovenoes MCT

Arm Description

Outcomes

Primary Outcome Measures

Evidence for immunoregulatory effect of lipid emulsion products.

Secondary Outcome Measures

Full Information

NCT ID

NCT00885781

First Posted

April 20, 2009

Last Updated

October 13, 2011

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00885781

Brief Title

Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

Official Title

Clinical Study Comparing Safety and Efficacy of SMOFlipid, the New Generation Fat Emulsion, in Comparison With the Current Fat Emulsion Lipovenoes MCT at the Hospital

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastrectomy, Malnutrition

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SMOFlipid

Arm Type

Experimental

Arm Title

Lipovenoes MCT

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

lipid emulsion for TPN

Other Intervention Name(s)

SMOFlipid 20%

Intervention Description

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

Primary Outcome Measure Information:

Title

Evidence for immunoregulatory effect of lipid emulsion products.

Time Frame

1-5 days after treatment provided

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age between 25 ~ 75 years old Postoperative (gastrectomy) patients required parental nutrition for at least 5 days Signed informed consent form Exclusion Criteria: Known hypersensitivity to fish-, egg- or soy protein or to any of the active substances or excipients 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 Severe liver insufficiency (total serum bilirubin ≧ 3 mg/dL or parental nutrition as a contraindication.) 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 Over weight (BMI> 30kg/m2) Severe blood coagulation disorders Inborn abnormality in amino acid metabolism Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis and hypotonic dehydration) Known diabetic ketoacidosis 7 days prior to randomization. Acute shock General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency Pregnancy or lactation Chemotherapy within 7 days before start of the trial 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 Already accept parental nutrition therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Tsan Lin, Dr.

Organizational Affiliation

Chief of General Suery department

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

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