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Search / Trial NCT06849011

Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

Launched by YAN ZHANG · Feb 23, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Enteral Nutrition Adverse Prognosis Prediction Model Non Traumatic Severe Brain Injury

ClinConnect Summary

This clinical trial is studying how to better predict the outcomes for patients with serious neurological conditions like stroke, encephalitis, or other severe brain injuries who are receiving a special type of feeding called enteral nutrition. Researchers want to create a tool that doctors can use to identify patients who are at higher risk for complications. By understanding certain markers related to inflammation and metabolism, the goal is to provide more personalized nutritional support to improve patient care.

To be eligible for this trial, participants need to be between 18 and 80 years old and have been admitted to the Neuro Intensive Care Unit (NICU) within a week of their illness. They should have a specific level of brain function and meet other health criteria. Importantly, participants must agree to join the study, either themselves or through a legal representative. If someone joins the trial, they can expect to receive close monitoring and care while their nutritional needs are assessed over at least a week. This study has not started recruiting participants yet, so there will be more information available once it begins.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age between 18 and 80 years, no gender restrictions.
  • 2. Within 7 days of disease onset and expected NICU stay of at least 7 days.
  • 3. Eligible for enrollment within 24 hours of NICU admission, with enteral nutrition (EN) initiated and continued for at least 7 days.
  • 4. Non-traumatic severe brain injury patients (including cerebrovascular disease and encephalitis) with a Glasgow Coma Scale (GCS) score ≤12.
  • 5. NRS 2002 score ≥3.
  • 6. Kuwata drinking test ≥ grade 3.
  • 7. Acute Gastrointestinal Injury (AGI) grade 1 or 2.
  • 8. Signed informed consent obtained from the patient or their legal representative.
  • Exclusion Criteria:
  • 1. Severe malnutrition prior to admission, defined as BMI \< 16 kg/m².
  • 2. Pregnant or lactating women.
  • 3. Receiving hypothermia treatment or core body temperature \< 36°C.
  • 4. 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.
  • 5. Malignant tumors.

About Yan Zhang

Yan Zhang is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in designing and managing innovative clinical studies, Yan Zhang focuses on a wide range of therapeutic areas, ensuring rigorous adherence to regulatory standards and ethical practices. Leveraging a collaborative approach, Yan Zhang works closely with research institutions and healthcare professionals to facilitate the development of safe and effective therapies. Their mission is to contribute to the scientific community through high-quality data generation and the promotion of evidence-based healthcare solutions.

Locations

Jinan, Shandong, China

Kunming, Yunnan, China

Beijing, Beijing, China

Taiyuan, Shanxi, China

Yinchuan, Ningxia, China

Hohhot, Inner Mongolia, China

Liaocheng, Shandong, China

Tangshan, Hebei, China

Zunyi, Guizhou, China

Guiyang, Guizhou, China

Suzhou, Jiangsu, China

Chifeng, Neimenggu, China

Jilin, Jilin, China

Beijing, Beijing, China

Beijing, Beijing, China

Beijing, Beijing, China

Lanzhou, Gansu, China

Shijiazhuang, Heibei, China

Jinan, Shandong, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported