Lactate Therapy After Traumatic Brain Injury
关键词
抽象
描述
Study: Prospective, single-centre phase II interventional study. The study will take place at the Department of Intensive Care Medicine, Lausanne University Medical Center (Centre Hospitalier Universitaire Vaudois, CHUV), Lausanne, Switzerland.
Patient population:
Patients will be monitored with an intra-parenchymal monitoring system, consisting of ICP (Codman®, Integra Neurosciences), PbtO2 (Licox®, Integra Neurosciences) and cerebral microdialysis (CMA Microdialysis®) catheters, based on the protocol for management of TBI presently in use at our center.
Each patient will receive a continuous infusion of sodium lactate (composition: lactate 1'000 mmol/L, Na 1'000 mmol/L: concentration 20-40 µmol/kg/min) for 3-6 hours. Sodium lactate will be prepared locally by the Pharmacie Centrale, CHUV, Lausanne.
Each patient will serve as his/her internal control, and the effect of sodium lactate on all brain physiological variables measured will be anayzed before, during and at the end of sodium lactate infusion.
The main parameters of efficacy are increases of MD glucose, MD pyruvate, PbtO2, and CBF, during sodium lactate perfusion.
For both MD glucose and MD pyruvate, we fixed as the minimal detectable effect of sodium lactate infusion a 30% increase of glucose and pyruvate at the end of the study. To obtain a power of 0.8 with an alpha of 0.05, the number of patients required to complete the study is 33. We therefore plan to include 35 patients.
Statistical analysis: At each time-point (baseline, during perfusion, end of sodium lactate infusion), differences of mean MD glucose, lactate, pyruvate, PbtO2, CBF, Mean transit time, ICP, CPP will be analyzed. We will also examine the percentage time spent with abnormal values (MD glucose < 1 mmol/L, PbtO2 < 20 mm Hg, ICP > 20 mm Hg). Differences will be compared using ANOVA for repeated measures.
日期
| 最后验证: | 02/28/2018 |
| 首次提交: | 03/31/2012 |
| 提交的预估入学人数: | 04/05/2012 |
| 首次发布: | 04/08/2012 |
| 上次提交的更新: | 03/29/2018 |
| 最近更新发布: | 04/02/2018 |
| 实际学习开始日期: | 02/29/2012 |
| 预计主要完成日期: | 11/30/2018 |
| 预计完成日期: | 11/30/2018 |
状况或疾病
干预/治疗
Other: sodium lactate infusion
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: sodium lactate infusion Continuous i.v. infusion of Sodium Lactate (2'400 mOsmol/L) over 3 hours | Other: sodium lactate infusion 3-6 hours continuous infusion of sodium lactate (20-40 mcg/kg/min) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Patients admitted to our intensive care unit (ICU) after severe TBI or poor-grade aneurysmal subarachnoid hemorrhage (SAH), defined by a post-resuscitation Glasgow Coma Scale (GCS) < 9 - Age 18-75 years - Abnormal head CT-scan (Marshall grade ≥ 2 or Fisher >2) - Intracranial pressure (ICP), PbtO2 and cerebral MD monitoring as part of standard care Exclusion Criteria: - Penetrating TBI - non aneurysmal SAH - Age < 18 or > 75 years, - More than 1 extra-cranial injury with sustained hemodynamic instability and sustained blood lactate elevation > 4 mmol/L - Cognitive handicap due to previous neurological or neurosurgical history - Non-survivable injury, brain death or expected death within 48 hours - Pregnancy |
结果
主要结果指标
1. Increase from baseline in brain extracellular lactate, pyruvate and glucose [6 hours]
次要成果指标
1. Increase from baseline in brain tissue PO2 [6 hours]
2. Increase from baseline in cerebral perfusion pressure [6 hours]
3. Decrease from baseline in intracranial pressure [6 hours]
4. plasma sodium [6 hours]
5. plasma osmolality [6 hours]
6. mean CBF, measured by transcranial doppler [6 hours]
