Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

April 10, 2017 updated by: Melbourne Health

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Intensive Care Unit, Royal Melbourne Hospital, Grattan Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame
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.
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.
Time Frame: participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.
participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melbourne Health

Investigators

  • Principal Investigator: Megan Robertson, Intensive Care Unit, Royal Melbourne Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

November 17, 2005

First Submitted That Met QC Criteria

November 17, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002.228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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