Intermittent Versus Continuous Feeding in ICU Patients

• ClinicalTrials.gov Identifier: NCT02358512
• Recruitment Status: Completed
• First Posted: February 9, 2015
• Last Update Posted: February 14, 2018
• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: University College, London; The Whittington Hospital NHS Trust
• Information provided by (Responsible Party): Guy's and St Thomas' NHS Foundation Trust

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)
• Actual Enrollment: 127 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
• Actual Primary Completion Date: January 2018
• Actual Study Completion Date: January 2018

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

Locations

United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, United Kingdom, SE1 9RT

Whittington Hospital NHS Trust

London, United Kingdom, W1T 7DA

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 of Results:

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].

Other Publications:

Puthucheary ZA, Hart N. Skeletal muscle mass and mortality - but what about functional outcome? Crit Care. 2014 Feb 17;18(1):110. doi: 10.1186/cc13729.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

McNelly AS, Bear DE, Connolly BA, Arbane G, Allum L, Tarbhai A, Cooper JA, Hopkins PA, Wise MP, Brealey D, Rooney K, Cupitt J, Carr B, Koelfat K, Damink SO, Atherton PJ, Hart N, Montgomery HE, Puthucheary ZA. Effect of Intermittent or Continuous Feed on Muscle Wasting in Critical Illness: A Phase 2 Clinical Trial. Chest. 2020 Jul;158(1):183-194. doi: 10.1016/j.chest.2020.03.045. Epub 2020 Apr 2.

• Responsible Party: Guy's and St Thomas' NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02358512
• Other Study ID Numbers: 14\LO\1792
• First Posted: February 9, 2015
• Last Update Posted: February 14, 2018
• Last Verified: February 2018

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

Additional relevant MeSH terms:

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases