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Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
This study is currently recruiting participants.
Study NCT00172198   Information provided by National Taiwan University Hospital
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
March 2005
 
  • 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
Same as current
No Changes Posted
  • Liver function(AST,ALT,bilirubin,ALP,rGT,albumin)
  • renal function(BUN,creatinine)
  • AC blood sugar
  • coagulation(INR,aPTT)
  • sodium
  • potassium
  • chloride
  • calcium
  • magnesium
  • phosphate
  • total white blood cell counts
  • platelets
  • haemoglobin
  • haematoc
Same as current
 
Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
A Prospective, Controlled, Randomized, Study Evaluating the Clinical Efficacy, Including Nutritional Status, Immune Function and Safety of Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
  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.
  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.
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Critical Ill Patients in SICU
Drug: Omegaven 10%
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
March 2007
 

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:

  • 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
Both
15 Years to 75 Years
No
Contact: Hong-Shiee Lai, MD, PhD 886-2-23123456 ext 5112 hslai@ha.mc.ntu.edu.tw
Taiwan
 
NCT00172198
 
183CL1
National Taiwan University Hospital
 
Principal Investigator: Hong-Shiee Lai, Professor National Taiwan University Hospital, Taipei, Taiwan
National Taiwan University Hospital
January 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP