Stroke, Time Restricted Feeding
Conditions
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.
Interventions
OTHERTime-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.
OTHERContinuous 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.
Sponsors
First Affiliated Hospital of Wannan Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Poor 90-day functional prognosis | Day 90 post-randomization | mRS ≥ 3 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mRS score at discharge | The day of Discharge, an average of 20 days | Modified Rankin Scale，the score ranges from 0\ 6 levels,and the higher the score, the more severe outcome |
| Barthel index at discharge | The day of Discharge, an average of 20 days | Barthel index at discharge |
| 90-day Barthel Index | Day 90 post-randomization | 90-day Barthel Index |
| ICU length of stay | From admission to ICU to transfer out of ICU .an average of 11 days | ICU length of stay |
| Length of hospital stay | The day of Discharge, an average of 20 days | total length of stay |
| GCS score at discharge | The day of Discharge, an average of 20 days | Glasgow Coma Scale,the score ranges from 3-15. The lower the score, the greater the impairment of consciousness |
| NIHSS score at discharge | The day of Discharge, an average of 20 days | NIH Stroke Scale,the score ranges from 0\ 42 points, and the higher the score, the more severe the nerve damage |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during hospitalization | From enrollment to discharge, an average of 20 days | Safety outcomes |
| 90-day mortality rate. | From enrollment to Day 90 post-randomization | Safety outcome |
| Serious adverse events during hospitalization | From enrollment to discharge, an average of 20 days | Safety outcome |
| 28-day mortality rate | From enrollment to Day 28 post-randomization | Safety outcome |
Countries
China
Outcome results
None listed