Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

NCT ID: NCT00256048

Last Updated: 2017-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2005-07-31

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.

Conditions

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Critically Ill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard Care

Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime

Group Type NO_INTERVENTION

No interventions assigned to this group

Nasojejunal Arm

Patient will receive feeding via a nasojejunal feeding tube

Group Type ACTIVE_COMPARATOR

Nasojejunal feeding

Intervention Type PROCEDURE

Interventions

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Nasojejunal feeding

Intervention Type PROCEDURE

Eligibility Criteria

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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.

\-

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. -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Melbourne Health

OTHER

Sponsor Role lead

Responsible Party

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Melbourne Health

Principal Investigators

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Megan Robertson

Role: PRINCIPAL_INVESTIGATOR

Intensive Care Unit, Royal Melbourne Hospital

Locations

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Intensive Care Unit, Royal Melbourne Hospital, Grattan Street

Parkville, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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2002.228

Identifier Type: -

Identifier Source: org_study_id

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