Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06577402

Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.

Led by Southeast University, China · Updated on 2024-08-29

6

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Evaluation of early energy metabolism and muscle mass changes in patients with severe brain injury, the impact of nutritional therapy on metabolism and muscle mass, and their relationship with patient prognosis, to provide clinical research references for the implementation of individualized nutritional therapy in patients with severe brain injury.

CONDITIONS

Official Title

Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with severe neurological critical illness admitted to the ICU, including moderate to severe acute cerebrovascular disease, severe acute craniocerebral injury and spinal cord injury, central nervous system bacterial infections, status epilepticus, neurosurgical patients requiring life support during the perioperative period, and other progressive severe neurological conditions.
  • Age 18 years or older.
  • Receiving invasive mechanical ventilation.
  • Willing to sign an informed consent form.
Not Eligible

You will not qualify if you...

  • Women of childbearing age with a positive pregnancy test, pregnant, or lactating women.
  • Chronic diseases with severe organ dysfunction or serious complications such as:
    1. Heart failure classified as New York Heart Association (NYHA) Functional Class IV.
    2. Chronic respiratory failure that requires long-term oxygen therapy.
    3. Chronic kidney disease stage 4 or 5.
    4. History of liver failure, hepatic encephalopathy, or hepatic coma; recent gastrointestinal bleeding due to portal hypertension; or Child-Pugh score of 10 or higher.
  • Cancer patients with cachexia or severe organ dysfunction due to tumor effects; recent chemotherapy or immunotherapy within one month.
  • Severe immunodeficiency or current use of strong immunosuppressants; agranulocytosis; active blood cancers; HIV stage III; or ongoing immunosuppressive induction therapy.
  • Acute gastrointestinal injury grade IV, including intestinal ischemia, necrosis, severe bleeding, or abdominal compartment syndrome needing decompression.
  • Implanted life-sustaining devices like pacemakers.
  • Critical condition with expected survival less than 24 hours.
  • Receiving or requiring dialysis or renal replacement therapy within 6 hours.
  • Receiving extracorporeal membrane oxygenation (ECMO) treatment.
  • Severe burns covering over 30% of body surface or significant third-degree burns; or burns with severe overall condition, shock, combined injuries, or respiratory tract burns.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhongda Hospital, Southeast university

Nanjing, Jiangsu, China

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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