Observing energy use and muscle changes in patients with severe brain injuries.

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

This study looks at how nutrition affects energy use and muscle changes in patients with severe brain injuries in the ICU to see if it can help improve their recovery.

Quick facts

• Study type: Observational
• Enrollment: 6 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Southeast University, China (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06577402 on ClinicalTrials.gov

What this trial studies

This observational study evaluates early changes in energy metabolism and muscle mass in patients suffering from severe brain injuries. It focuses on the effects of nutritional therapy on these parameters and their correlation with patient prognosis. By analyzing these factors, the study aims to provide insights for implementing personalized nutritional strategies for affected individuals. The research involves patients admitted to the ICU who are receiving invasive mechanical ventilation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with severe neurological conditions requiring intensive care and mechanical ventilation.

Not a fit: Patients who are pregnant, lactating, or have severe chronic diseases with organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved nutritional therapies that enhance recovery outcomes for patients with severe brain injuries.

How similar studies have performed: While similar studies have explored nutritional interventions in critical care, this specific focus on severe brain injury and its metabolic implications is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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 old.
* Receiving invasive mechanical ventilation.
* Willing to sign an informed consent form.

Exclusion Criteria:

* Women of childbearing age with a positive pregnancy test, pregnant, or lactating women.
* Chronic diseases with severe organ dysfunction or serious complications:

  1. Heart: New York Heart Association (NYHA) Functional Classification IV.
  2. Lung: Chronic respiratory failure requiring long-term oxygen therapy.
  3. Kidney: Chronic kidney disease stage 4 or 5; Liver: History of liver failure, hepatic encephalopathy, or hepatic coma, recent gastrointestinal bleeding due to portal hypertension, or Child-Pugh score ≥ 10.
* Cancer patients with cachexia, or with severe organ dysfunction due to obstruction, mass effect, compression, or those who have not undergone surgery due to difficulty or recent chemotherapy or immunotherapy within one month.
* Severe immunodeficiency or current use of potent immunosuppressants, agranulocytosis (N \< 0.5×10\^9/L), active hematologic malignancy, or HIV infection stage III; currently undergoing immunosuppressive induction therapy, such as antithymocyte globulin (ATG), antilymphocyte globulin (ALG), interleukin 2 receptor alpha chain antibody (IL-2RA), interleukin 6 receptor A antibody (IL-6RA), etc.; continuous use of glucocorticoids for more than 2 weeks, with a daily dose exceeding the equivalent of 200 mg of hydrocortisone.
* Acute gastrointestinal injury (AGI) grade IV, such as intestinal ischemia and necrosis, gastrointestinal bleeding leading to hemorrhagic shock, abdominal compartment syndrome (IAP \> 20mmHg) requiring active decompression, etc.
* Implanted with life-sustaining devices such as a pacemaker.
* In a critical condition with an expected survival time of less than 24 hours.
* Receiving or requiring dialysis or renal replacement therapy within 6 hours (this time frame is considered to exclude patients who may have acute changes in renal function that could confound the study outcomes or who may be in a transient state that could resolve without the need for long-term dialysis or renal replacement therapy).
* Patients requiring or currently receiving extracorporeal membrane oxygenation (ECMO) treatment.
* Combined with severe and above burns: total body surface area of burns exceeding 30% or III-degree burns area exceeding 10%; or with a total area of less than 30%, but with a severe overall condition or in shock, combined injuries, or respiratory tract burns.

Where this trial is running

Nanjing, Jiangsu

• Zhongda Hospital, Southeast university — Nanjing, Jiangsu, China (RECRUITING)

Conditions: Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain Injury