Intermittent Versus Continuous Feeding in ICU Patients

February 13, 2018 updated by: Guy's and St Thomas' NHS Foundation Trust

A Phase 2 Pilot Physiological Randomised Clinical Trial to Investigate the Effect of Intermittent Versus Continuous Enteral Nutrition on Muscle Wasting in Critical Illness

The purpose of this study is to determine whether intermittent nasogastric enteral feeding, rather than conventional continuous enteral feeding, will preserve muscle mass in the critically ill (Primary end-point). Such maintenance may translate into improved outcomes including reduced length of intensive care unit (ICU) and/or hospital stay, as well as number of days on a ventilator. In addition, long-term improvements in health-related quality of life and physical activity levels may result in these ICU survivors once they are back in the community. Indeed, such benefits could translate into reductions in primary healthcare usage and its related costs (secondary end-points).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II pilot single-blinded randomized controlled trial to be conducted in two adult intensive care units. Technically, the patient will be blinded (by virtue of illness), and in any case knowledge of the feeding intervention they are receiving would not influence outcome. Scans will be taken by staff who could potentially be aware of treatment; keeping scanner personnel blinded would involve complex logistics to separate those randomising, scanning patients, and collecting data; however, the investigators don't think that the individuals taking the scans would introduce material bias. Importantly, all scans will be analysed by the same individual (based off-site) who will be blind to treatment status.

Within 24 hours of admission to ICU, patients recruited to the study will be randomised to either intermittent enteral feeding or continuous enteral feeding - both regimens delivering the same nutritional content over a 24 hour period. The intermittent feeding regimen will consist of six bolus feeds (one bolus every four hours) while the continuous feeding regimen consists of the total volume of feed administered over 24 hours. Feed volume in both groups will commence according to a standard 'usual practice' protocol so as not to delay feeding, but each patient will then have an individual regimen calculated by the dietician. Feeding will continue as either intermittent or continuous for the duration of the trial period as tolerated.

Ultrasound of the thigh (enabling derivation of the Rectus Femoris cross sectional area (RFCSA)) will be performed on Days 1,7,10 (or at discharge, if sooner), and at hospital discharge (if after Day 10), with blood and urine samples taken daily. The hospital discharge destination will be noted, and functional assessment will be determined prior to hospital discharge by two validated methods previously used in this patient cohort (6-Minute Walk Distance and Short Performance Battery Test). Patients' health-related quality of life (HRQOL) will be determined for the pre-morbid period and at 12 months post ICU-discharge using the Short Form-36 health survey; primary care costs since discharge will also be ascertained.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE1 9RT
        • Guy's & St Thomas' NHS Foundation Trust
      • London, United Kingdom, W1T 7DA
        • Whittington Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Due to receive enteral nutrition via nasogastric tube as part of routine care; endotracheally intubated and mechanically ventilated; likely to remain intubated for 48 hours; likely to remain on the ICU for >7 days; and to survive intensive care admission.

Exclusion Criteria:

  • Pregnancy
  • Active disseminated malignancy (diagnosed or suspected)
  • Unilateral/bilateral lower limb amputees
  • Single Organ Failure (SOFA score less than 2)
  • Patients with a primary neuromyopathy
  • Patients entered into trials of interventions which would affect muscle mass
  • Patients assessed as requiring sole/supplemental parenteral nutrition or post-pyloric feeding
  • Patients requiring extra-corporeal membrane oxygenation (ECMO)
  • Patients not meeting nutritional requirements in 72 hours using a standard feeding schedule
  • Patients requiring the use of high protein feed
  • Admission to ICU within the previous 3 months
  • Ward patients who have received artificial enteral tube feeding within this hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent enteral feeding
The intermittent feeding regimen will consist of six bolus feeds (one bolus every four hours).
Other: Enteral feeding
Bolus feeds or continuous feeds during a 10-day ICU stay
Active Comparator: Continuous enteral feeding
The continuous feeding regimen consists of the total volume of feed administered over 24 hours.
Other: Enteral feeding
Bolus feeds or continuous feeds during a 10-day ICU stay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rectus Femoris cross-sectional area
Time Frame: Change between Day 1 and Day 10
Change between Day 1 and Day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay on ICU
Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2.5 weeks
Participants will be followed for the duration of ICU stay, an expected average of 2.5 weeks
Length of hospital stay
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4.5 weeks
Participants will be followed for the duration of hospital stay, an expected average of 4.5 weeks
Discharge Location
Time Frame: At hospital discharge, an expected average of 4.5 weeks after admission
At hospital discharge, an expected average of 4.5 weeks after admission
Number of days on ventilator
Time Frame: Ventilator days during ICU stay, an expected average of 2.5 weeks
Ventilator days during ICU stay, an expected average of 2.5 weeks
6 Minute Walk Distance and Short Performance Battery Test
Time Frame: At hospital discharge, an expected average of 4.5 weeks after admission
These tests will assess participant's functional ability
At hospital discharge, an expected average of 4.5 weeks after admission
Health-related quality of life
Time Frame: 12 months post-ICU discharge
Using Short Form-36 (SF-36) questionnaire via telephone
12 months post-ICU discharge
Number of General Practitioner (GP) and nurse consultations
Time Frame: 12 months post-ICU discharge
This will provide primary care costs and allow derivation of health economic parameters, Quality-Adjusted Life Years and Cost Utility Ratios.
12 months post-ICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

University College, London
The Whittington Hospital NHS Trust

Investigators

  • Principal Investigator: Nicholas Hart, PhD, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14\LO\1792

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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