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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2005 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172198
First received: September 12, 2005
Last updated: NA
Last verified: January 2005
History: No changes posted
  Purpose
  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.

Condition Intervention Phase
Critical Ill Patients in SICU
Drug: Omegaven 10%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 30
Study Start Date: March 2005
Estimated Study Completion Date: March 2007
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.
  Eligibility

Ages Eligible for Study:   15 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00172198

Contacts
Contact: Hong-Shiee Lai, MD, PhD 886-2-23123456 ext 5112 hslai@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Hong-Shiee Lai, M.D., Ph.D.    886-2-23123456 ext 5112    hslai@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Hong-Shiee Lai, Professor National Taiwan University Hospital, Taipei, Taiwan
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00172198     History of Changes
Other Study ID Numbers: 183CL1
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
w-3 fish oil
Nutrition
immune
intensive care
patients

ClinicalTrials.gov processed this record on October 20, 2014