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Intermittent Versus Continuous Feeding in ICU Patients

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ClinicalTrials.gov Identifier: NCT02358512
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Intensive Care (ICU) Myopathy Other: Enteral feeding Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Physiological Randomised Clinical Trial to Investigate the Effect of Intermittent Versus Continuous Enteral Nutrition on Muscle Wasting in Critical Illness
Actual Study Start Date : February 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Rectus Femoris cross-sectional area [ Time Frame: Change between Day 1 and Day 10 ]

Secondary Outcome Measures :
  1. Length of stay on ICU [ Time Frame: Participants will be followed for the duration of ICU stay, an expected average of 2.5 weeks ]
  2. Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4.5 weeks ]
  3. Discharge Location [ Time Frame: At hospital discharge, an expected average of 4.5 weeks after admission ]
  4. Number of days on ventilator [ Time Frame: Ventilator days during ICU stay, an expected average of 2.5 weeks ]
  5. 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

  6. Health-related quality of life [ Time Frame: 12 months post-ICU discharge ]
    Using Short Form-36 (SF-36) questionnaire via telephone

  7. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT02358512


Contacts
Contact: Angela McNelly, PhD 020 3447 2843 angela.mcnelly.10@ucl.ac.uk

Locations
United Kingdom
Guy's & St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Nicholas Hart, PhD    020 7188 6115    Nicholas.Hart@gstt.nhs.uk   
Whittington Hospital NHS Trust Recruiting
London, United Kingdom, W1T 7DA
Contact: Hugh Montgomery, MD    020 3447 2806    h.montgomery@ucl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
University College, London
The Whittington Hospital NHS Trust
Investigators
Principal Investigator: Nicholas Hart, PhD Guy's and St Thomas' NHS Foundation Trust
More Information

Publications:
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02358512     History of Changes
Other Study ID Numbers: 14\LO\1792
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Intensive Care
Recovery of Function
Survivors
Outcome Assessment (Health Care)
Medical Economics