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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06161948
• Other study ID #: 2023AH040243
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: October 2023
• Source: First Affiliated Hospital of Wannan Medical College
• Contact: Tao Yu, doctor
• Phone: 18855392038
• Email: dryutao2022[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: October 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Time Restricted Feeding

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	The first affliated hospital of Wannan medical college	Wuhu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Wannan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor 90-day functional prognosis	mRS = 3 points	90-day
Secondary	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
Secondary	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
Secondary	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
Secondary	Barthel index at discharge	Barthel index at discharge	average of 32-day
Secondary	90-day Barthel Index	90-day Barthel Index	90-day
Secondary	ICU length of stay	ICU length of stay	13-day
Secondary	total length of stay	total length of stay	average of 32-day
Secondary	Nutritional status	albumin, prealbumin, hemoglobin, transferrin levels	7-day,14-day,28-day
Secondary	Electrolyte levels	serum potassium, serum sodium, serum phosphorus, serum magnesium levels	7-day,14-day,28-day