NCT00172198

Brief Summary

  1. 1.A prospective, controlled, randomized, study evaluating the clinical efficacy, including nutritional status, immune function and safety of Omegaven (ω-3 fish oil) supplemented parenteral nutrition in subjects of SICU.
  2. 2.Study patients are the critical ill patients in SICU of NTUH and the enrolled patients will be 30 subjects ,including 15 in each treatment group.
  3. 3.During parenteral nutrition, fat emulsions will be given separately from amino acid and glucose solutions. Infusion pump must be used.The recommended infusion duration of the daily lipid emulsion is 16 hours (0.0625 g fat/kg B.W./hour) from 8:00 am to 12:00 pm.
  4. 4.During the study the assessments of safety and efficacy are to be performed according to case report form. The assessment for safety variables including blood pressure、heat rate 、body temperature、liver function、renal function、coagulation、WBC、lipid profile etc. In addition，the assessments for efficacy variables including lymphocytes、cytokines(IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α etc)、incidence of infections、 length of ICU and hospital stay、mortality etc.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

September 15, 2005

Status Verified

January 1, 2005

First QC Date

September 12, 2005

Last Update Submit

September 12, 2005

Conditions

Critical Ill Patients in SICU

Keywords

w-3 fish oilNutritionimmuneintensive carepatients

Outcome Measures

Primary Outcomes (3)

  • Lymphocytes:T4,T8,B,T,NK

  • Cytokine secretion:IL-1、IL-2、IL-6、IL-8、IL-11、IL-18、OX40 ligand、G-CSF、FN-γ、TGF-β1、TNF-α.

  • Clinical outcome:incidence of infections,length of ICU and hospital stay,ventilation,mortality

Secondary Outcomes (14)

  • Liver function(AST,ALT,bilirubin,ALP,rGT,albumin)

  • renal function(BUN,creatinine)

  • AC blood sugar

  • coagulation(INR,aPTT)

  • sodium

  • +9 more secondary outcomes

Interventions

Omegaven 10%DRUG

Eligibility Criteria

Age15 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients between 15 and 75 years of age
  • Expected ICU stay and TPN support requirement \> 7 days
  • Hemodynamically stable
  • Serum bilirubin \< 2.5 mg/dl
  • Serum creatinine \< 1.4 mg/dl
  • INR (international Normalized ratio of PT) \< 1.4
  • Written informed consent from the subject

You may not qualify if:

  • Pregnant or lactating women. (Pre-menopause women, capable of bearing children will undergo pregnancy test)
  • General contraindications of infusion therapy; acute pulmonary oedema,hyperhydration and decompensated cardiac insufficiency
  • Known hypersensitivity to egg- or soy protein or any of the ingredients
  • Severe blood coagulation disorders
  • Shock necessitating acute resuscitation at the discretion of the investigator
  • Diabetes mellitus with known ketoacidosis within 7 days of onset of study treatment
  • APACHE II score \> 25
  • Renal insufficiency defined as serum creatinine value of \>1.4 mg/dl
  • Subjects with severe liver dysfunction which contraindicates the use of parenteral nutrition at the discretion of the investigator
  • Unconscious or uncooperative patients
  • Participation in a clinical study with an investigational drug or an investigational medical device within one month prior to start of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • Roulet M, Frascarolo P, Pilet M, Chapuis G. Effects of intravenously infused fish oil on platelet fatty acid phospholipid composition and on platelet function in postoperative trauma. JPEN J Parenter Enteral Nutr. 1997 Sep-Oct;21(5):296-301. doi: 10.1177/0148607197021005296.

    PMID: 9323693BACKGROUND

Study Officials

  • Hong-Shiee Lai, Professor

    National Taiwan University Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong-Shiee Lai, MD, PhD

CONTACT

886-2-23123456hslai@ha.mc.ntu.edu.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2007

Last Updated

September 15, 2005

Record last verified: 2005-01

Locations

TW(1)