Status:

COMPLETED

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

Lead Sponsor:

First Affiliated Hospital of Wannan Medical College

Conditions:

Stroke

Time Restricted Feeding

Eligibility:

All Genders

18-80 years

Phase:

NA

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...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 15 2024

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 12 2025

Estimated Enrollment :

420 Patients enrolled

Trial Details

Trial ID

NCT06161948

Start Date

January 15 2024

End Date

December 12 2025

Last Update

January 2 2026

Active Locations (1)

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1

The first affliated hospital of Wannan medical college

Wuhu, China