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Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00256048
First Posted: November 21, 2005
Last Update Posted: April 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Melbourne Health
  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
Critically Ill Procedure: Nasojejunal feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Melbourne Health
ClinicalTrials.gov Identifier: NCT00256048     History of Changes
Other Study ID Numbers: 2002.228
First Submitted: November 17, 2005
First Posted: November 21, 2005
Last Update Posted: April 12, 2017
Last Verified: April 2015

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes