Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172198
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
Omegaven w-3 Fish Oil Supplemented Parenteral Nutrition in Subjects of SICU
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 usedThe recommended infusion duration of the daily lipid emulsion is 16 hours 00625 g fatkg BWhour from 800 am to 1200 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 pressureheat rate body temperatureliver functionrenal functioncoagulationWBClipid profile etc In additionthe assessments for efficacy variables including lymphocytescytokinesIL-1IL-2IL-6IL-8IL-11IL-18OX40 ligandG-CSFFN-γTGF-β1TNF-α etcincidence of infections length of ICU and hospital staymortality etc
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 usedThe recommended infusion duration of the daily lipid emulsion is 16 hours 00625 g fatkg BWhour from 800 am to 1200 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 pressureheat rate body temperatureliver functionrenal functioncoagulationWBClipid profile etc In additionthe assessments for efficacy variables including lymphocytescytokinesIL-1IL-2IL-6IL-8IL-11IL-18OX40 ligandG-CSFFN-γTGF-β1TNF-α etcincidence of infections length of ICU and hospital staymortality etc
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 usedThe recommended infusion duration of the daily lipid emulsion is 16 hours 00625 g fatkg BWhour from 800 am to 1200 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 pressureheat rate body temperatureliver functionrenal functioncoagulationWBClipid profile etc In additionthe assessments for efficacy variables including lymphocytescytokinesIL-1IL-2IL-6IL-8IL-11IL-18OX40 ligandG-CSFFN-γTGF-β1TNF-α etcincidence of infections length of ICU and hospital staymortality etc
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 usedThe recommended infusion duration of the daily lipid emulsion is 16 hours 00625 g fatkg BWhour from 800 am to 1200 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 pressureheat rate body temperatureliver functionrenal functioncoagulationWBClipid profile etc In additionthe assessments for efficacy variables including lymphocytescytokinesIL-1IL-2IL-6IL-8IL-11IL-18OX40 ligandG-CSFFN-γTGF-β1TNF-α etcincidence of infections length of ICU and hospital staymortality etc
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None