Efficacy of Nasojejunal Enteral Feeding in Critically Ill... | NCT00256048

Studies
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.

NCT00256048

Sponsor

Melbourne Health

Status

Completed

Last Update Posted

Apr 12, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Critically Ill

Interventions

Nasojejunal feeding

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005Actual

First Submitted Date

Nov 17, 2005

First Submission Date that Met QC Criteria

Nov 17, 2005

First Posted Date

Nov 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2017

Last Update Posted Date

Apr 12, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nasojejunal feeding	Procedure		Nasojejunal Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Patients who consent or if the patient is incompetent, the next of kin, who consent, to inclusion in the study.

-

Exclusion Criteria:

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. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Megan Robertson	Intensive Care Unit, Royal Melbourne Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intensive Care Unit, Royal Melbourne Hospital, Grattan Street		Parkville	Victoria	3050	Australia

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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