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An intensive care unit randomised trial - comparing two approaches to providing nutrition during critical illness

A feasibility randomised controlled trial of administering daytime-only enteral feeding compared to standard continuous enteral feeding, to reduce delirium in mechanically ventilated, critically ill adults, with qualitative and circadian mechanistic sub-studies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81745275
Enrollment
40
Registered
2025-11-27
Start date
2025-11-03
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical illness and delirium Other

Interventions

This trial has been designed as a feasibility study to inform a future definitive randomised controlled trail
exploring trial recruitment and retention, feasibility and acceptability of data collection procedures, and outcome measures, intervention fidelity and evidence of efficacy. In standard care for this

Sponsors

University Hospitals Plymouth NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Adults (aged 18 years and above)  2. Unplanned admission to ICU within 48 hours of admission 3. Mechanically ventilated, with a clinical view it will be for >48 hours  4. Plan to start enteral feeding (providing nutrition via a tube into the gastrointestinal tract) or enteral feeding has commenced during the daytime only so far  5. Likely to require enteral feeding for >48 hours

Exclusion criteria

Exclusion criteria: 1. Planned admissions unless unexpectedly ventilated during the first 24 hours of admission 2. Continuous enteral feeding already commenced overnight (22:00-08:00)  3. Known intolerance to enteral feeding or currently unable to absorb enteral feed  4. Post-emergency bowel surgery  5. Type 1 diabetes or pre-existing insulin therapy (with risk of significant dysglycaemia on fasting for 10 hours)  6. Hyponatraemia; serum Na <115 mmol/L 7. Nil-by-mouth 8. Clinician considers daytime-only feeding unsuitable for the patient  9. Pregnancy and breastfeeding 10. Post-pyloric feeding via jejunostomy tube  11. Receiving parenteral nutrition  12. Dementia, psychosis, bipolar disorder and pre-existing use of antipsychotic drugs (haloperidol, olanzapine, quetiapine) or alcohol use, daily and to excess 13. Prone position ventilation

Countries

England, United Kingdom

Contacts

Public ContactTim Macdonald
daydream.penctu@plymouth.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026