Improvement of Therapy in Patients With Severe Traumatic Brain Injury: Differential Impact of Local and Systemic Changes and Routinely Applied Drugs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- plasma glutamine levels
研究概览
简要总结
Severe traumatic brain injury is associated with life-threatening and incapacitating secondary injury.
Contemporary therapeutic interventions are aimed at preventing and treating secondary damage. In this context, improved cerebral metabolism is an important target in modern neurointensive care.
The main hypothesis is that continuous intravenous infusion of glutamyl-alanyl dipeptide restores disturbed brain metabolism following severe traumatic brain injury.
详细描述
Patients suffering from severe traumatic brain injury and requiring multimodal neuromonitoring during pharmacological coma will receive alanyl-glutamine dipeptide (Dipeptiven) as part of standard clinical nutrition.
In two groups of patients the influence of different duration of infusion (group 1: 24 hours; group 2: 5 days) will be investigated. For this, pharmacokinetic and pharmacodynamic parameters in plasma and brain are determined.
Increased plasma glutamine and alanine in arterial and jugular venous plasma and in cerebral microdialysates are to reflect efficacy of Dipeptiven infusion.
Plasma glutamate levels as well as changes in cerebral glutamate, lactate, lactate/pyruvate ratio, intracranial pressure, bispectral index electroencephalography will be measured to exclude potential adverse effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •severe traumatic brain injury
- •prolonged pharmacologic coma
- •multimodal neuromonitoring (microdialysis, ptiO2)
- •enteral nutrition
排除标准
- •patients anticipated to decease within 48 hours
- •abdominal injury
- •mass transfusion
- •renal impairment
- •hepatic impairment
- •barbiturate coma
- •parenteral nutrition
- •weight below 50 kg
- •weight above 100 kg
研究组 & 干预措施
Dipeptiven
0.75 g/ kg/ d Dipeptiven ( L- alanine- L- glutamine; 82 mg/ ml L- alanine, 134.6 mg/ ml L- glutamine; Fresenius Kabi, Switzerland) continuous intravenous infusion
干预措施: Dipeptiven (Drug)
结局指标
主要结局
plasma glutamine levels
时间窗: 2 to 7 days
changes in plasma glutamine levels during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (micromole/ liter) or relative (%) values
cerebral glutamine
时间窗: 2 to 7 days
changes in cerebral glutamine levels during and after infusion of alanyl-glutamine compared to baseline and intra-infusion values expressed in absolute (micromole/ liter) or relative (%) values
次要结局
- cerebral lactate to pyruvate ratio(2 to 7 days)
- intracranial pressure(2 to 7 days)
- bispectral index electroencephalography(2 to 7 days)
- cerebral lactate(2 to 7 days)
- cerebral glutamate(2 to 7 days)
研究者
John Stover
Prof. Dr. med.
University of Zurich