NCT00256048

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2015

First QC Date

November 17, 2005

Last Update Submit

April 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

Standard Care

NO INTERVENTION

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

Nasojejunal Arm

ACTIVE COMPARATOR

Patient will receive feeding via a nasojejunal feeding tube

Procedure: Nasojejunal feeding

Interventions

Nasojejunal Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
  • Patients commenced on enteral feeding via a nasogastric tube who fail to tolerate gastric feeding due to excessive gastric aspirate volumes.

You may not qualify if:

  • patients less than 18 years of age.
  • Patients with known allergy to promotility agents, metoclopramide or erythromycin.
  • Patients with a contra indication to nasojejunal feeding. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Royal Melbourne Hospital, Grattan Street

Parkville, Victoria, 3050, Australia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Megan Robertson

    Intensive Care Unit, Royal Melbourne Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2005

First Posted

November 21, 2005

Study Start

May 1, 2003

Study Completion

July 1, 2005

Last Updated

April 12, 2017

Record last verified: 2015-04

Locations