The first affliated hospital of Wannan medical college
Wuhu, China
NCT Number: NCT06161948
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Wuhu, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 90 post-randomization
mRS ≥ 3 points
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: The day of Discharge, an average of 20 days
Barthel index at discharge
Time frame: Day 90 post-randomization
90-day Barthel Index
Time frame: From admission to ICU to transfer out of ICU .an average of 11 days
ICU length of stay
Time frame: The day of Discharge, an average of 20 days
total length of stay
Time frame: From enrollment to discharge, an average of 20 days
Safety outcomes
Time frame: From enrollment to discharge, an average of 20 days
Safety outcome
Time frame: From enrollment to Day 28 post-randomization
Safety outcome
Time frame: From enrollment to Day 90 post-randomization
Safety outcome
First Affiliated Hospital of Wannan Medical College
Other
The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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