Intermittent Versus Continuous Feeding in ICU Patients

NCT02358512 | Completed Phase 2 DMC

• 1 other identifier: 14\LO\1792
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 2

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).

Conditions

Intensive Care (ICU) Myopathy

Keywords

Intensive Care; Recovery of Function; Survivors; Outcome Assessment (Health Care); Medical Economics

Outcome Measures

Primary Outcomes (1)

• Rectus Femoris cross-sectional area

  Change between Day 1 and Day 10

Secondary Outcomes (7)

• Length of stay on ICU

  Participants will be followed for the duration of ICU stay, an expected average of 2.5 weeks

• Length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 4.5 weeks

• Discharge Location

  At hospital discharge, an expected average of 4.5 weeks after admission

• Number of days on ventilator

  Ventilator days during ICU stay, an expected average of 2.5 weeks

• 6 Minute Walk Distance and Short Performance Battery Test

  At hospital discharge, an expected average of 4.5 weeks after admission

Study Arms (2)

Intermittent enteral feeding

EXPERIMENTAL

The intermittent feeding regimen will consist of six bolus feeds (one bolus every four hours).

Other: Enteral feeding

Continuous enteral feeding

ACTIVE COMPARATOR

The continuous feeding regimen consists of the total volume of feed administered over 24 hours.

Other: Enteral feeding

Interventions

Enteral feeding OTHER

Bolus feeds or continuous feeds during a 10-day ICU stay

Continuous enteral feeding; Intermittent enteral feeding

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University College, London: collaborator
• The Whittington Hospital NHS Trust: collaborator

Study Sites (2)

Guy's & St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

Whittington Hospital NHS Trust

London, W1T 7DA, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 24528611 BACKGROUND

• 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. doi: 10.1001/jama.2013.278481.

  PMID: 24108501 RESULT

• Wilkinson D, Gallagher IJ, McNelly A, Bear DE, Hart N, Montgomery HE, Le Guennec A, Conte MR, Francis T, Harridge SDR, Atherton PJ, Puthucheary ZA. The metabolic effects of intermittent versus continuous feeding in critically ill patients. Sci Rep. 2023 Nov 9;13(1):19508. doi: 10.1038/s41598-023-46490-5.

  PMID: 37945671 DERIVED

• 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.

  PMID: 32247714 DERIVED

MeSH Terms

Conditions

Muscular Diseases

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Nicholas Hart, PhD

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 9, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

GB (2)