Elevated Serum-lactate in Patients With Brain Tumor During and After Elective Craniotomy: an Observational Clinical Study of Postoperative Patient Outcome.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Neurological disability
研究概览
简要总结
This study aims to investigate the association between hyperlactatemia and neurological disability, length-of-stay and mortality in patients who undergo tumorcraniotomy. The risk factors that induce lactat accumulation will also be explored.
详细描述
Hyperlactatemia is a frequent occurrence in brain tumor surgery. The existing studies, however, are all retrospective, reporting varying effects on clinical outcome. One study reported new neurological deficitis, some found an association with extended hospital stay, while others found no association with outcome. It is therefore important to conduct a prospective study of hyperlactatemia in this patientgroup.
Participants in this study will follow the standard treatment protocol for tumorcraniotomy, aside from 2-3 additional, perioperative blodgas analyses and 2 standardized measurements of neurological disability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 18 years
- •Must undergo elective tumor craniotomy
- •Understand oral and written Danish
排除标准
- •Adults with incapacity
- •Stereotactic biopsy
- •Lack of informed and signed consent to participate in study
结局指标
主要结局
Neurological disability
时间窗: Change from baseline mRS at 30 days after surgery
Modified Rankin Scale (Scoring 0-6, high scores meaning worse outcome)
次要结局
- Length of hospital stay(1 year)
- Mortality(After 30 days, 6 months and 5 years)
研究者
Alexandra Vassilieva
Principal investigator
Rigshospitalet, Denmark