Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain InjuryNCT06577402
Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.
An observational study of Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain Injury, run by Southeast University, China at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain Injury
- What is being tested?
- nutritional support
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 15 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with critical neurological illness
Who may be able to join
- 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.
Who cannot join
- Women of childbearing age with a positive pregnancy test, pregnant, or lactating women.
- Chronic diseases with severe organ dysfunction or serious complications:
- Heart: New York Heart Association (NYHA) Functional Classification IV.
- Lung: Chronic respiratory failure requiring long-term oxygen therapy.
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital, Southeast university
Nanjing, Jiangsu
Airan Liu, PhD, 15295557466, airanliu@126.com
About this study
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.
- Being tested
- nutritional support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional supportDietary supplement
nutritional support
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal Metabolic Rate
Measured: first 10 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start15 Apr 2024
- Primary completion15 Apr 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577402
- Sponsor's protocol ID
- 2024ZDSYLL109-P01
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.
- ClinicalTrials.gov ID
- NCT06577402
- Acronym / sponsor ID
- 2024ZDSYLL109-P01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with critical neurological illness
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Women of childbearing age with a positive pregnancy test, pregnant, or lactating women.
- Chronic diseases with severe organ dysfunction or serious complications:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional supportnutritional support | Dietary supplement | – |
Primary outcome
Basal Metabolic Rate
Time frame: first 10 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Energy Metabolism and Muscle Mass Changes in Patients With Severe Brain Injury, run by Southeast University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Basal Metabolic Rate (time frame: first 10 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.