Clinical trial NCT00256048: Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Official title: Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2005-11-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
2. Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.
3. Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.

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Exclusion Criteria:

1. patients less than 18 years of age.
2. Patients with known allergy to promotility agents, metoclopramide or erythromycin.
3. Patients with a contra indication to nasojejunal feeding. -

Primary outcomes:
measure: Efficacy of feeding
timeFrame: participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
Secondary outcomes:
measure: 1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
timeFrame: participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
measure: 2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
timeFrame: participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
state: Victoria
Study officials:
affiliation: Intensive Care Unit, Royal Melbourne Hospital
name: Megan Robertson
role: PRINCIPAL_INVESTIGATOR
References: