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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Stroke, Time Restricted Feeding

Intervention / Treatment
-----------------
* Other: Time-restricted enteral nutrition therapy group
* Other: Continuous enteral nutrition control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years old and <80 years old; Cerebral parenchymal hemorrhage or cerebral infarction within 72 hours of onset; GCS score ≤12 points or NIHSS score ≥11 points on admission, Enteral nutrition is planned, and the estimated enteral nutrition treatment time is ≥7 days; Signed informed consent form. Exclusion Criteria: Complete parenteral nutrition is required due to contraindications to enteral nutrition; After gastrectomy or intestinal resection; Enteral nutrition treatment has been performed for >12 hours; Accompanying diseases: a. Advanced cancer; b. Severe cardiac insufficiency [ejection fraction ≤ 50%]; c. Severe liver failure [Child Pugh score ≥ 7]; d. Severe renal failure [glomerular filtration] rate ≤ 30 mL/min or serum creatinine ≥ 4 mg/dL]) Have a history of mental illness or mRS ≥ 3 points; The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient; During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of <90 days; The patient participates in another clinical study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time-restricted group<br>Time-restricted enteral nutrition therapy group | Other: Time-restricted enteral nutrition therapy group<br>* 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.<br>|
| Other: Continuous group<br>Continuous enteral nutrition control group | Other: Continuous enteral nutrition control group<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Poor 90-day functional prognosis | mRS ≥ 3 points | 90-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCS score at discharge | Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness | average of 32-day | 
| 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 | average of 32-day | 
| mRS score at discharge | Modified Rankin Scale，the score ranges from 0 6 levels,and the higher the score, the more severe outcome | average of 32-day | 
| Barthel index at discharge | Barthel index at discharge | average of 32-day | 
| 90-day Barthel Index | 90-day Barthel Index | 90-day | 
| ICU length of stay | ICU length of stay | 13-day | 
| total length of stay | total length of stay | average of 32-day | 
| Nutritional status | albumin, prealbumin, hemoglobin, transferrin levels | 7-day,14-day,28-day | 
| Electrolyte levels | serum potassium, serum sodium, serum phosphorus, serum magnesium levels | 7-day,14-day,28-day |