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Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

This study has been completed.
Sponsor:
Information provided by:
Melbourne Health
ClinicalTrials.gov Identifier:
NCT00256048
First received: November 17, 2005
Last updated: February 3, 2009
Last verified: February 2009
  Purpose

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.


Condition Intervention
Intensive Care Patients Requiring Enteral Feeding.
Procedure: Nasojejunal feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

Further study details as provided by Melbourne Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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. ]
  • 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. ]

Enrollment: 50
Study Start Date: May 2003
Study Completion Date: July 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

    -

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256048

Locations
Australia, Victoria
Intensive Care Unit, Royal Melbourne Hospital, Grattan Street
Parkville, Victoria, Australia, 3050
Sponsors and Collaborators
Melbourne Health
Investigators
Principal Investigator: Megan Robertson Intensive Care Unit, Royal Melbourne Hospital
  More Information

No publications provided

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00256048     History of Changes
Other Study ID Numbers: 2002.228
Study First Received: November 17, 2005
Last Updated: February 3, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014