Efficacy and Safety Comparison Between SMOFlipid and Lipovenoes MCT

Malnutrition Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885781
• Other study ID #: 200803090M
• Secondary ID: SMOF-002-I P4
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2009
• Last updated: October 13, 2011
• Start date: November 2008
• Est. completion date: December 2010

Study information

• Verified date: May 2011
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastrectomy
• Malnutrition

Intervention

Drug:
• lipid emulsion for TPN
1-2 g lipid emulsion /kgBW-day, for consecutive 5 days

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence for immunoregulatory effect of lipid emulsion products.		1-5 days after treatment provided	Yes