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Status unknownNCT00172198Updated Sep 15, 2005

Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.

A Phase 4 interventional study of Omegaven 10% in Critical Ill Patients in SICU, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 15 Years to 75 Years. Per ClinicalTrials.gov, last updated 2005-09-15.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2005), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
15 Years to 75 Years
Sex
All
01

Study summary

  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. 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. 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. 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.
Read the detailed description
  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. 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. 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. 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.
02

Conditions studied

  • Critical Ill Patients in SICU

Keywords

  • w-3 fish oil
  • Nutrition
  • immune
  • intensive care
  • patients
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Known type IV hyperlipidemia, disturbances in lipid metabolism or hypertriglyceridemia (at the time of inclusion, a blood sample (fasting) for serum triglyceride assessment has to be taken. The sample has to be analysed before start of trial treatment. In case of fasting serum triglyceride value of >4 mmol/l (>354 mg/dl) the subject must be withdrawn.
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
30 participants

Interventions

  • DrugOmegaven 10%
06

What researchers measure

Primary outcomes

  1. Lymphocytes:T4,T8,B,T,NK

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

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

Secondary outcomes

  1. Liver function(AST,ALT,bilirubin,ALP,rGT,albumin)

  2. renal function(BUN,creatinine)

  3. AC blood sugar

  4. coagulation(INR,aPTT)

  5. sodium

  6. potassium

  7. chloride

  8. calcium

  9. magnesium

  10. phosphate

  11. total white blood cell counts

  12. platelets

  13. haemoglobin

  14. haematoc

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Publications

  • 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. PubMed 9323693 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00172198
Lead sponsor
National Taiwan University Hospital
First posted
Sep 15, 2005
Start date
Mar 2005
Completion
Mar 2007
Last update
Sep 15, 2005

Study contacts

Hong-Shiee Lai, MD, PhD
Contact
hslai@ha.mc.ntu.edu.tw
886-2-23123456 ext. 5112
Hong-Shiee Lai, Professor
principal investigator · National Taiwan University Hospital, Taipei, Taiwan
View the source record on ClinicalTrials.gov ↗

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