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

Sponsor:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00172198

Purpose

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.
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.
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.
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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Fish oil

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:

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

Detailed Description:

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.
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.
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.
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

Criteria

Inclusion 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

Contacts and Locations

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

Contacts

Contact: Hong-Shiee Lai, MD, PhD

886-2-23123456 ext 5112

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:

Study ID Numbers:	183CL1
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00172198 History of Changes
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 November 25, 2009