Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Tracking Information | |||||
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First Received Date ICMJE | November 17, 2005 | ||||
Last Updated Date | February 3, 2009 | ||||
Start Date ICMJE | May 2003 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Efficacy of feeding [ Time Frame: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00256048 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients. | ||||
Official Title ICMJE | Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients. | ||||
Brief Summary | The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients. The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents. |
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Detailed Description | The study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a nasogastric with the addition of promotility agents for patients who fail to absorb their enteral nutrition. This study compares the efficacy of nasojejunal feeding feeding with nasogastric enteral feeding with the addition of promotility agents. The duration of feeding will be determined by the patients nutritional requirements and their general condition. However the data will be collected for duration of enteral feeding, 28 days or ICU discharge whichever occurs first. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Intensive Care Patients Requiring Enteral Feeding. | ||||
Intervention ICMJE | Procedure: Nasojejunal feeding | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 50 | ||||
Completion Date | July 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Australia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256048 | ||||
Other Study ID Numbers ICMJE | 2002.228 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Melbourne Health | ||||
Study Sponsor ICMJE | Melbourne Health | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Melbourne Health | ||||
Verification Date | February 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |