- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00172198
Omegaven (w-3 Fish Oil) Supplemented Parenteral Nutrition in Subjects of SICU.
September 12, 2005 updated by: National Taiwan University Hospital
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.
- 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.
Study Overview
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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hong-Shiee Lai, MD, PhD
- Phone Number: 5112 886-2-23123456
- Email: hslai@ha.mc.ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Hong-Shiee Lai, M.D., Ph.D.
- Phone Number: 5112 886-2-23123456
- Email: hslai@ha.mc.ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 75 years (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
platelets
|
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
|
haemoglobin
|
haematoc
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hong-Shiee Lai, Professor, National Taiwan University Hospital, Taipei, Taiwan
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
March 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 12, 2005
Last Verified
January 1, 2005
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 183CL1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Critical Ill Patients in SICU
-
Hopital of MelunCompletedCritical Ill Patients | Ventilated PatientsFrance
-
French Society for Intensive CareCompleted
-
Assiut UniversityUnknownDiaphragmatic Dysfunction in Critically Ill Patients
-
Assiut UniversityCompletedSedation in Critically Ill COPD Patients
-
University of ChicagoTerminatedJugular Venous Pulse Measurement in Critically Ill PatientsUnited States
-
Shanghai Zhongshan HospitalNot yet recruitingEmergency Tracheal Intubation in Critically Ill Patients
-
University of PittsburghNational Institute on Aging (NIA)CompletedPhysician-Family Communication in Intensive Care Units | Surrogate Decision-making for Critically Ill Patients | Critically Ill Intensive Care Unit PatientsUnited States
-
Goethe UniversityUnknownDrug Monitoring of Antiinfectives in Critically Ill Patients Receiving Extracorporeal Life SupportGermany
-
Michigan State UniversityCompletedPharmacokinetics of Avycaz in ICU Patients
-
University Hospital Southampton NHS Foundation...CompletedCritical Ill Patients
Clinical Trials on Omegaven 10%
-
Georgetown UniversityApproved for marketingCholestasis of Parenteral NutritionUnited States
-
General University Hospital, PragueCharles University, Czech Republic; Ministry of Health, Czech RepublicCompletedParenteral NutritionCzechia
-
Children's Hospital Los AngelesCompleted
-
Humanis Klinikum NiederosterreichCompleted
-
Sir Run Run Shaw HospitalUnknown
-
Children's & Women's Health Centre of British ColumbiaChild and Family Research InstituteUnknownCholestasis | Parenteral Nutrition Associated Liver Disease (PNALD)Canada
-
Midwestern Regional Medical CenterTerminatedCancer | Hepatic InjuryUnited States
-
Jagiellonian UniversityCompletedGastrointestinal SurgeryPoland
-
Radboud University Medical CenterCompleted