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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
420
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.
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.
The first affliated hospital of Wannan medical college
Wuhu, China
Poor 90-day functional prognosis
mRS ≥ 3 points
Time frame: Day 90 post-randomization
GCS score at discharge
Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness
Time frame: The day of Discharge, an average of 20 days
NIHSS score at discharge
NIH Stroke Scale,the score ranges from 0\~42 points, and the higher the score, the more severe the nerve damage
Time frame: The day of Discharge, an average of 20 days
mRS score at discharge
Modified Rankin Scale,the score ranges from 0\~6 levels,and the higher the score, the more severe outcome
Time frame: The day of Discharge, an average of 20 days
Barthel index at discharge
Barthel index at discharge
Time frame: The day of Discharge, an average of 20 days
90-day Barthel Index
90-day Barthel Index
Time frame: Day 90 post-randomization
ICU length of stay
ICU length of stay
Time frame: From admission to ICU to transfer out of ICU .an average of 11 days
Length of hospital stay
total length of stay
Time frame: The day of Discharge, an average of 20 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.