Rationale and design of a PROBE trial comparing continuous enteral nutrition to time-restricted enteral nutrition in severe stroke

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BACKGROUND AND PURPOSE: Continuous enteral nutrition treatment is routinely provided in the intensive care unit (ICU) for patients with critically ill stroke and contributes to circadian rhythm disruption because a time-limited diet is part of the normal biological rhythm of diurnal species. Our study aims to evaluate the safety as well as the effectiveness of time-restricted enteral nutrition in ICU patients who have had a severe stroke. METHODS AND DESIGN: The Time-restricted Enteral Nutrition vs continuous Enteral nutriTion (TENET) research is a multicentre, prospective, randomised, open-blinded, endpoint trial that compares continuous enteral nutrition to time-restricted enteral nutrition in persons who have had a severe stroke. People with severe stroke who score ≥11 points on the National Institutes of Health Stroke Scale (NIHSS) or ≤12 points on the Glasgow Coma Scale (GCS) will be included and randomly assigned to restrict the duration of daytime enteral nutrition to 8-12 hours (time-limited enteral nutrition group) or a 24-hour cycle of continuous enteral nutrition (control group). Until the patient stops receiving enteral nutritional support, passes away, is moved out of the ICU or enteral nutrition is used for 28 days, whichever occurs first, enteral nutritional support will continue. Every patient will have a 90-day follow-up. STUDY OUTCOMES: A poor 90-day functional prognosis (which is indicated by a ≥3 points modified Rankin scale (mRS) score) is the primary efficacy endpoint. The secondary efficacy endpoints include the GCS, NIHSS, mRS, the Barthel index (all recorded at discharge), the 90-day Barthel index and the duration of ICU stay. The safety outcomes include adverse events and serious adverse events during hospitalisation, along with the 28- and 90-day mortality. DISCUSSION: Clinical evidence for the safety as well as effectiveness of time-restricted enteral nutrition in persons with severe stroke will be provided by this TENET study. TRIAL REGISTRATION NUMBER: NCT06161948.

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