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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00256048
Other study ID # 2002.228
Secondary ID
Status Completed
Phase N/A
First received November 17, 2005
Last updated April 10, 2017
Start date May 2003
Est. completion date July 2005

Study information

Verified date April 2015
Source Melbourne Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nasojejunal feeding


Locations

Country Name City State
Australia Intensive Care Unit, Royal Melbourne Hospital, Grattan Street Parkville Victoria

Sponsors (1)

Lead Sponsor Collaborator
Melbourne Health

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
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