NCT06161948

Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke

The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: First Affiliated Hospital of Wannan Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In patients with severe stroke whose GCS score is ≤12 points or NIHSS score is ≥11 points, to evaluate whether time-restricted enteral nutrition can improve the incidence of poor 90-day prognosis (mRS ≥3 points) compared with continuous enteral nutrition.

Detailed description

Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 \~ 08:00, end time: 16:00 \~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first. On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d. The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first. On the first day of enrollment: the patient is given 1/3 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; On the second day of enrollment: the patient is given 1/2 of the estimated energy and 1.2-1.5g/kg/d of protein through enteral nutrition; Enrollment 3 - End of intervention: The patient is given 100% of the estimated energy through enteral nutrition, which can fluctuate between 70% and 100% of the estimated energy, and the protein is 1.2-1.5g/kg/d.

Conditions

• Stroke
• Time Restricted Feeding

Interventions

Type	Name	Description
OTHER	Time-restricted enteral nutrition therapy group	Control the daily enteral nutrition time to 8-12 hours, enteral nutrition start time: 06:00 \~ 08:00, end time: 16:00 \~ 18:00. Enteral nutrition lasts until the patient discontinues enteral nutrition, the patient dies, the patient is transferred from the ICU, or enteral nutrition is used until 28 days, whichever event occurs first.
OTHER	Continuous enteral nutrition control group	The control group was continuous enteral nutrition (24 hours), which lasted until the patient stopped taking enteral nutrition, the patient died, the patient was transferred from the ICU, or enteral nutrition was used until 28 days, whichever event occurred first.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-07-12
• Completion: 2025-12-12
• First posted: 2023-12-08
• Last updated: 2026-01-02

Locations

1 site across 1 country: China