Clinical trial NCT06161948: Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Time Restricted Feeding
Lead sponsor: First Affiliated Hospital of Wannan Medical College
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Poor 90-day functional prognosis
timeFrame: 90-day
Secondary outcomes:
measure: GCS score at discharge
timeFrame: average of 32-day
measure: NIHSS score at discharge
timeFrame: average of 32-day
measure: mRS score at discharge
timeFrame: average of 32-day
measure: Barthel index at discharge
timeFrame: average of 32-day
measure: 90-day Barthel Index
timeFrame: 90-day
measure: ICU length of stay
timeFrame: 13-day
measure: total length of stay
timeFrame: average of 32-day
measure: Nutritional status
timeFrame: 7-day,14-day,28-day
measure: Electrolyte levels
timeFrame: 7-day,14-day,28-day
Other outcomes:
Locations:
city: Wuhu
country: China
facility: The first affliated hospital of Wannan medical college
Study officials:
affiliation: First Affiliated Hospital of Wannan Medical College
name: Tao Yu, doctor
role: PRINCIPAL_INVESTIGATOR
References: