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NCT06161948Completed

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

The Effect of Time-restricted Enteral Nutrition on the Prognosis of Severe Stroke Patients: a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial

Source: ClinicalTrials.gov · Last updated 2 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
420 (actual)
First submitted
19 Nov 2023
Start date
15 Jan 2024
Primary completion date
12 Jul 2025
Lead sponsor
First Affiliated Hospital of Wannan Medical College
Diseases
Stroke
NCT number
NCT06161948

What you commit to

  • Study type: Interventional
  • Participants enrolled: 420
  • From 15 Jan 2024 to the primary completion date, 12 Jul 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • After gastrectomy or intestinal resection;

Other illness

  • Have a history of mental illness or mRS ≥ 3 points;
  • During the patient's admission, death is inevitable, and there are underlying diseases that result in a survival time of \<90 days;

Lab values

  • 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\])

Other

  • Complete parenteral nutrition is required due to contraindications to enteral nutrition;
  • Enteral nutrition treatment has been performed for \>12 hours;
  • The patient's doctor or nutritional therapist believes that the plan is not in the best interest of the patient;
  • The patient participates in another clinical study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affliated Hospital of Wannan Medical College
Coordinator of this site? Confirm its status
WuhuChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.