Not Yet RecruitingNot Applicable

Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

China1,185 participantsStarted 2025-03-01

Plain-language summary

The study aims to develop and validate a prognostic prediction model for adverse outcomes in neurocritical patients receiving enteral nutrition based on key inflammatory and metabolic markers. This model will serve as a clinical tool to help physicians identify high-risk patients and guide individualized nutritional support strategies.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age between 18 and 80 years, no gender restrictions.
✓. Within 7 days of disease onset and expected NICU stay of at least 7 days.
✓. Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
✓. Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
✓. NRS 2002 score ≥3.
✓. Kuwata drinking test ≥ grade 3.
✓. Acute Gastrointestinal Injury (AGI) grade 1 or 2.
✓. Signed informed consent obtained from the patient or their legal representative.

Exclusion criteria

✕. Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
✕. Pregnant or lactating women.
✕. Receiving hypothermia treatment or core body temperature \< 36°C.
✕. End-stage disease with an expected survival time of \< 48 hours, or severe dysfunction of the heart, lungs, or other vital organs, leading to hemodynamic instability.
✕. Malignant tumors.

What they're measuring

All-cause mortality at Day 28 of enteral nutrition therapy

Timeframe: From enrollment to 28 days after the initiation of enteral nutrition

Trial details

NCT IDNCT06849011

SponsorYan Zhang

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Yan Zhang, MD., Ph D.

8613671376710 zhangylq@sina.com

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