Status:
UNKNOWN
Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Critical Ill Patients in SICU
Eligibility:
All Genders
15-75 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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354 mg/dl) the subject must be withdrawn.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
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00172198
Start Date
March 1 2005
End Date
March 1 2007
Last Update
September 15 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100