Time-restricted Enteral Nutrition Versus Continuous Enteral Nutrition in Patients With Severe Stroke
- Conditions
- StrokeTime Restricted Feeding
- Interventions
- Other: Continuous enteral nutrition control groupOther: Time-restricted enteral nutrition therapy group
- Registration Number
- NCT06161948
- Lead Sponsor
- First Affiliated Hospital of Wannan Medical College
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 420
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous group Continuous enteral nutrition control group Continuous enteral nutrition control group Time-restricted group Time-restricted enteral nutrition therapy group Time-restricted enteral nutrition therapy group
- Primary Outcome Measures
Name Time Method Poor 90-day functional prognosis 90-day mRS ≥ 3 points
- Secondary Outcome Measures
Name Time Method Barthel index at discharge average of 32-day Barthel index at discharge
mRS score at discharge average of 32-day Modified Rankin Scale，the score ranges from 0\~6 levels,and the higher the score, the more severe outcome
GCS score at discharge average of 32-day Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness
90-day Barthel Index 90-day 90-day Barthel Index
Nutritional status 7-day,14-day,28-day albumin, prealbumin, hemoglobin, transferrin levels
Electrolyte levels 7-day,14-day,28-day serum potassium, serum sodium, serum phosphorus, serum magnesium levels
NIHSS score at discharge average of 32-day NIH Stroke Scale,the score ranges from 0\~42 points, and the higher the score, the more severe the nerve damage
ICU length of stay 13-day ICU length of stay
total length of stay average of 32-day total length of stay
Trial Locations
- Locations (1)
The first affliated hospital of Wannan medical college
🇨🇳Wuhu, China