Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

Conditions
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Critically Ill

Intervention / Treatment
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* Procedure: Nasojejunal feeding


Participation Criteria
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Eligibility Criteria
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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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime | |
| Active Comparator: Nasojejunal Arm<br>Patient will receive feeding via a nasojejunal feeding tube | Procedure: Nasojejunal feeding<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of feeding |  | participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes. |  | participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission. | 
| 2. To assess the efficacy of current strategies for optimising enteral feeding efficacy. |  | participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission. |