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NCT Number: NCT06849011

Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hui People's Hospital, Beijing, Beijing Municipality, China

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About this study

A multi-center, prospective case data collection study will be conducted across 19 tertiary hospitals in China. Based on this, a predictive assessment model for poor prognosis in neurocritically ill patients receiving enteral nutrition support will be developed and validated, using key inflammatory and metabolic markers. During the data collection process, comprehensive clinical information will be extracted, including patient demographic data, clinical indicators, and hematological markers. By conducting in-depth analysis and processing of this vast and detailed clinical and laboratory data, a nomogram for predicting poor prognosis in neurocritical care patients receiving enteral nutrition support will be constructed using statistical methods and data analysis techniques in R. Once the model is built, it will undergo rigorous validation on an independent external dataset to ensure its accuracy and reliability. The goal is to create a precise assessment tool for clinicians, helping them to quickly and accurately identify high-nutritional-risk patients, thereby providing a solid scientific foundation for the formulation of individualized nutrition support strategies, ultimately improving the prognosis of neurocritical patients.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality at Day 28 of enteral nutrition therapy

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

Secondary outcomes

  1. Nutritional goal achievement rate at Day 3 (caloric and protein intake reaching 70%-100% of calculated target)

    Time frame: At Day 3 after the initiation of enteral nutrition

  2. Adverse outcome rate at Day 90 (defined as a Modified Rankin Scale score ≥ 3)

    Time frame: At Day 90 after the initiation of enteral nutrition

  3. Incidence of infectious complications within 14 days (including pneumonia, urinary tract infections, bloodstream infections, skin infections, and Clostridium difficile infections)

    Time frame: Within 14 days after the initiation of enteral nutrition

  4. Gastrointestinal intolerance within 14 days (gastric residual volume > 200 mL, nausea, vomiting, bloating, diarrhea)

    Time frame: Within 14 days after the initiation of enteral nutrition

    The gastric residual volume is assessed every 4 hours by the nurse through aspiration via the nasogastric tube. Other clinical manifestations such as nausea, vomiting, bloating, and diarrhea are assessed through daily observation by the attending physician.

  5. Incidence of gastrointestinal bleeding within 14 days (gastric occult blood, fecal occult blood, hematemesis, melena, hematochezia)

    Time frame: Within 14 days after the initiation of enteral nutrition

  6. Number of days with random blood glucose > 10 mmol/L within 14 days

    Time frame: Within 14 days after the initiation of enteral nutrition

  7. Average daily insulin requirement within 14 days

    Time frame: Within 14 days after the initiation of enteral nutrition

  8. Incidence of hypophosphatemia within 3 days

    Time frame: Within 3 days after the initiation of enteral nutrition

  9. Duration of mechanical ventilation within 14 days

    Time frame: Within 14 days after the initiation of enteral nutrition

  10. Length of NICU stay

    Time frame: From enrollment to discharge from the NICU, up to 1 year.

  11. Total hospital stay duration

    Time frame: From enrollment to discharge, up to 1 year.

  12. 90-day readmission rate post-discharge

    Time frame: Within 90 days after discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Fei Tian, MD., Ph D.

CONTACT

[email protected]

8618201303685

Yan Zhang, MD., Ph D.

CONTACT

[email protected]

8613671376710

Sponsors and collaborators

Lead sponsor

Yan Zhang

Other

Registry information

Official study title

Development and Validation of a Prognostic Prediction Model for Adverse Outcomes in Neurocritical Patients Receiving Enteral Nutrition Based on Key Inflammatory and Metabolic Markers

Acronym: IMPACT-NEURO

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 27, 2025
Registry last updated
Feb 27, 2025

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.

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