Back to resultsEfficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Primary Purpose
Critically Ill
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Nasojejunal feeding
Sponsored by
About this trial
This is an interventional treatment trial for Critically Ill
Eligibility Criteria
Inclusion Criteria: Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours. Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes. Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study. - Exclusion Criteria: patients less than 18 years of age. Patients with known allergy to promotility agents, metoclopramide or erythromycin. Patients with a contra indication to nasojejunal feeding. -
Sites / Locations
- Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Care
Nasojejunal Arm
Arm Description
Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime
Patient will receive feeding via a nasojejunal feeding tube
Outcomes
Primary Outcome Measures
Efficacy of feeding
Secondary Outcome Measures
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00256048
Brief Title
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Official Title
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Melbourne Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime
Arm Title
Nasojejunal Arm
Arm Type
Active Comparator
Arm Description
Patient will receive feeding via a nasojejunal feeding tube
Intervention Type
Procedure
Intervention Name(s)
Nasojejunal feeding
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Time Frame
participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
Title
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Time Frame
participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.
-
Exclusion Criteria:
patients less than 18 years of age.
Patients with known allergy to promotility agents, metoclopramide or erythromycin.
Patients with a contra indication to nasojejunal feeding. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Megan Robertson
Organizational Affiliation
Intensive Care Unit, Royal Melbourne Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
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