Stroke Clinical Trial - Time-restricted Enteral Nutrition Versus

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06161948
Study type	Interventional
Source	First Affiliated Hospital of Wannan Medical College
Contact	Tao Yu, doctor
Phone	18855392038
Email	dryutao2022@163.com
Status	Recruiting
Phase	N/A
Start date	January 1, 2024
Completion date	October 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms