Skip to main content
OpenTrials
Completed

NCT Number: NCT06161948

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The first affliated hospital of Wannan medical college

Wuhu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time-restricted enteral nutrition therapy group

Other

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.

Continuous enteral nutrition control group

Other

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.

Primary outcomes

  1. Poor 90-day functional prognosis

    Time frame: Day 90 post-randomization

    mRS ≥ 3 points

Secondary outcomes

  1. GCS score at discharge

    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

  2. NIHSS score at discharge

    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

  3. mRS score at discharge

    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

  4. Barthel index at discharge

    Time frame: The day of Discharge, an average of 20 days

    Barthel index at discharge

  5. 90-day Barthel Index

    Time frame: Day 90 post-randomization

    90-day Barthel Index

  6. ICU length of stay

    Time frame: From admission to ICU to transfer out of ICU .an average of 11 days

    ICU length of stay

  7. Length of hospital stay

    Time frame: The day of Discharge, an average of 20 days

    total length of stay

Other outcomes

  1. Adverse events during hospitalization

    Time frame: From enrollment to discharge, an average of 20 days

    Safety outcomes

  2. Serious adverse events during hospitalization

    Time frame: From enrollment to discharge, an average of 20 days

    Safety outcome

  3. 28-day mortality rate

    Time frame: From enrollment to Day 28 post-randomization

    Safety outcome

  4. 90-day mortality rate.

    Time frame: From enrollment to Day 90 post-randomization

    Safety outcome

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Wannan Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
Jan 2, 2026

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.

Published trials that share one or more normalized conditions with this study.