NCT06577402招募中不适用
Observational Study on Energy Expenditure and Protein Metabolism Changes in Patients With Severe Brain Injury.
Southeast University, China1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年4月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Basal Metabolic Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •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.
结局指标
主要结局
Basal Metabolic Rate
时间窗: first 10 day
次要结局
未报告次要终点
研究者
Ling Liu
Attending Physician
Southeast University, China
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Posttraumatic Changes in Energy Expenditure and Body Composition in Patients With Acute Spinal Cord InjurySpinal Cord InjuriesNCT01980784Swiss Paraplegic Research, Nottwil25
招募中
不适用
Metabolism Evaluation Through Resting Indirect Calorimetry in Bladder Cancer (METRICS)Bladder CancerNCT06721260University of Kansas Medical Center30
已完成
不适用
METabolism After Orthopedic SurgeryOrthopedic DisorderMetabolism and Nutrition DisorderNCT05864833I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio51
已完成
不适用
A Longitudinal Investigation of Energy Expenditure and Substrate Utilization in Critically Ill PatientsCritical IllnessNCT05124860Karolinska University Hospital714
已完成
不适用
Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)COVID-19NCT04350073Duke University65