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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affliated Hospital of Wannan Medical College Coordinator of this site? Confirm its status | Wuhu | China | Unknown status |
Related publications
- Rationale and design of a PROBE trial comparing continuous enteral nutrition to time-restricted enteral nutrition in severe stroke.Stroke Vasc Neurol · 2026 · PMID 41339081
This page is information, not medical advice. Discuss any trial with your doctor.