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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Critical Ill Patients in SICU	Drug: Omegaven 10%	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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.
Study Start Date :	March 2005
Study Completion Date :	March 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	15 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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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.

ClinicalTrials.gov Identifier:	NCT00172198 History of Changes
Other Study ID Numbers:	183CL1
First Posted:	September 15, 2005
Last Update Posted:	September 15, 2005
Last Verified:	January 2005

Keywords provided by National Taiwan University Hospital:

w-3 fish oil; Nutrition; immune; intensive care; patients