Inflammatory and Metabolic Prognostic Assessment in Critically Ill Neurological Patients (IMPACT-NEURO)

February 23, 2025 updated by: Yan Zhang

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

1185

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 100053
        • Beijing Hui People's Hospital
        • Contact:
      • Beijing, Beijing, China, 100069
        • You'anmen Hospital
        • Contact:
      • Beijing, Beijing, China, 100700
        • The Ninth Medical Center of Chinese PLA General Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • The 940th Hospital of Joint Logistics Support Force of Chinese PLA
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
        • Contact:
      • Zunyi, Guizhou, China, 563003
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hebei
      • Tangshan, Hebei, China, 063000
        • Tangshan People's Hospital
        • Contact:
    • Heibei
      • ShijiaZhuang, Heibei, China, 050031
        • The First Hospital of Hebei Medical University
        • Contact:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 010017
        • Inner Mongolia Autonomous Region People's Hospital
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • The Second Affiliated Hospital of Suzhou University
        • Contact:
    • Jilin
      • Jilin, Jilin, China, 130021
        • The First hospital of Jilin University
        • Contact:
    • Neimenggu
      • Chifeng, Neimenggu, China, 024000
        • Chifeng Municipal Hospital
        • Contact:
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
        • Contact:
      • Jinan, Shandong, China, 250031
        • The 960th Hospital of Joint Logistics Support Force of Chinese PLA
        • Contact:
      • Liaocheng, Shandong, China, 252000
        • Liaocheng people's Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • The Second Hospital of Shanxi Medical University
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • The First People's Hospital of Yunnan Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of critically ill neurocritical patients in the acute phase who are receiving enteral nutrition (EN) treatment in the Neurocritical Care Unit (NICU).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
mild Inflammation & Metabolic dysfunction
First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.
Moderate Inflammation & Metabolic Dysregulation
First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.
High Inflammation & Severe Metabolic Dysregulation
First, a predictive model for poor prognosis is constructed through screening of independent variables after data collection. Then, stratified analysis is conducted with inflammatory markers such as C-reactive protein and interleukin-6, and metabolic markers such as blood glucose and insulin dosage.
Peptide-Based Nutrition
Select patients who received peptide-based formulas from the entire database for poor prognosis analysis.
Whole Protein Nutrition
Select patients who received whole protein formulas from the database for poor prognosis analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality at Day 28 of enteral nutrition therapy
Time Frame: From enrollment to 28 days after the initiation of enteral nutrition
From enrollment to 28 days after the initiation of enteral nutrition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At Day 3 after the initiation of enteral nutrition
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
At Day 90 after the initiation of enteral nutrition
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
Within 14 days after the initiation of enteral nutrition
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.
Within 14 days after the initiation of enteral nutrition
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
Within 14 days after the initiation of enteral nutrition
Number of days with random blood glucose > 10 mmol/L within 14 days
Time Frame: Within 14 days after the initiation of enteral nutrition
Within 14 days after the initiation of enteral nutrition
Average daily insulin requirement within 14 days
Time Frame: Within 14 days after the initiation of enteral nutrition
Within 14 days after the initiation of enteral nutrition
Incidence of hypophosphatemia within 3 days
Time Frame: Within 3 days after the initiation of enteral nutrition
Within 3 days after the initiation of enteral nutrition
Duration of mechanical ventilation within 14 days
Time Frame: Within 14 days after the initiation of enteral nutrition
Within 14 days after the initiation of enteral nutrition
Length of NICU stay
Time Frame: From enrollment to discharge from the NICU, up to 1 year.
From enrollment to discharge from the NICU, up to 1 year.
Total hospital stay duration
Time Frame: From enrollment to discharge, up to 1 year.
From enrollment to discharge, up to 1 year.
90-day readmission rate post-discharge
Time Frame: Within 90 days after discharge
Within 90 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yan Zhang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 23, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xwzc202500102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be shared. Available data includes demographic information, clinical characteristics, laboratory results, and outcome measures.

IPD Sharing Time Frame

Data will be available upon reasonable request from 6 months after study completion to 3 years post-publication.

IPD Sharing Access Criteria

Access will be granted to qualified researchers upon reasonable request through a formal data-sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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