Intensive Care (ICU) MyopathyPhase 2NCT02358512
Intermittent Versus Continuous Feeding in ICU Patients
A Phase 2 study testing Enteral feeding in people with Intensive Care (ICU) Myopathy, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU) Myopathy
- What is being tested?
- Enteral feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2015to Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's & St Thomas' NHS Foundation Trust
London, SE1 9RT
Whittington Hospital NHS Trust
London, W1T 7DA
About this study
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
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).
Read the 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.
- Conditions
- Intensive Care (ICU) Myopathy
- Being tested
- Enteral feeding
- Keywords
- Intensive Care, Recovery of Function, Survivors, Outcome Assessment (Health Care), Medical Economics
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral feedingOther
Bolus feeds or continuous feeds during a 10-day ICU stay
| Study group | Role | What they receive |
|---|---|---|
| Intermittent enteral feeding | Experimental | The intermittent feeding regimen will consist of six bolus feeds (one bolus every four hours). Receives: Other: Enteral feeding |
| Continuous enteral feeding | Active comparator | The continuous feeding regimen consists of the total volume of feed administered over 24 hours. Receives: Other: Enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rectus Femoris cross-sectional area
Measured: Change between Day 1 and Day 10
Secondary outcomes (7)
Length of stay on ICU
Measured: Participants will be followed for the duration of ICU stay, an expected average of 2.5 weeks
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4.5 weeks
Discharge Location
Measured: At hospital discharge, an expected average of 4.5 weeks after admission
Number of days on ventilator
Measured: Ventilator days during ICU stay, an expected average of 2.5 weeks
6 Minute Walk Distance and Short Performance Battery Test
These tests will assess participant's functional ability
Measured: At hospital discharge, an expected average of 4.5 weeks after admission
Health-related quality of life
Using Short Form-36 (SF-36) questionnaire via telephone
Measured: 12 months post-ICU discharge
Number of General Practitioner (GP) and nurse consultations
This will provide primary care costs and allow derivation of health economic parameters, Quality-Adjusted Life Years and Cost Utility Ratios.
Measured: 12 months post-ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intensive Care (ICU) MyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, The Whittington Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Nicholas Hart, PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358512
- Sponsor's protocol ID
- 14\LO\1792
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2015
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 24528611Puthucheary 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.
PubMed 24108501Wilkinson 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.
PubMed 37945671McNelly 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.
PubMed 32247714
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02358512
- Acronym / sponsor ID
- 14\LO\1792
- Conditions
- Intensive Care (ICU) Myopathy
- Keywords
- Intensive Care, Recovery of Function, Survivors, Outcome Assessment (Health Care), Medical Economics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College, London, The Whittington Hospital NHS Trust
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent enteral feeding | Experimental | Other: Enteral feedingThe intermittent feeding regimen will consist of six bolus feeds (one bolus every four hours). |
| Continuous enteral feeding | Active comparator | Other: Enteral feedingThe continuous feeding regimen consists of the total volume of feed administered over 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral feedingBolus feeds or continuous feeds during a 10-day ICU stay | Other | Continuous enteral feeding, Intermittent enteral feeding |
Primary outcome
Rectus Femoris cross-sectional area
Time frame: Change between Day 1 and Day 10
7 secondary outcomes
Length of stay on ICU
Time frame: 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
Discharge Location
Time frame: 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
6 Minute Walk Distance and Short Performance Battery Test
Time frame: At hospital discharge, an expected average of 4.5 weeks after admission
Health-related quality of life
Time frame: 12 months post-ICU discharge
Number of General Practitioner (GP) and nurse consultations
Time frame: 12 months post-ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2018.
- Background: PubMed 24528611Puthucheary 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.
- Results publication: PubMed 24108501Puthucheary 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.
- Derived from this study: PubMed 37945671Wilkinson 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.
- Derived from this study: PubMed 32247714McNelly 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Hart, PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enteral feeding in people with Intensive Care (ICU) Myopathy, run by Guy's and St Thomas' NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rectus Femoris cross-sectional area (time frame: Change between Day 1 and Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358512, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2018.