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临床试验/NCT06393049
NCT06393049
已完成
不适用

Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients With Severe Acute Brain Injury

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 14 人2024年5月8日

概览

阶段
不适用
干预措施
Hyperglycaemic clamp
疾病 / 适应症
Acute Brain Injury
发起方
Rigshospitalet, Denmark
入组人数
14
试验地点
2
主要终点
(Change in) MD-glucose (mmol/L)
状态
已完成
最后更新
2个月前

概览

简要总结

Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. It is common clinical practice, but the interaction between the body's sugar levels and the brain's sugar levels is not sufficiently elucidated.

The study will investigate the relationship between the body's sugar levels, measured in arterial and venous blood, and the brain's sugar level, measured by microdialysis, in patients with severe acute brain injury.

Furthermore, we hope to be able to use our measurements to set up a mathematical model for the brain's sugar uptake.

注册库
clinicaltrials.gov
开始日期
2024年5月8日
结束日期
2025年12月31日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Anne-Sophie Worm Fenger

Principal investigator, MD, PhD fellow

Rigshospitalet, Denmark

入排标准

入选标准

  • Age ≥ 18 years.
  • Admission to the neuro-ICU at Rigshospitalet.
  • Multimodal neuromonitoring

排除标准

  • Closest relative does not understand written and spoken Danish or English.
  • Patients with known diabetes mellitus upon admission.

研究组 & 干预措施

Hyperglycaemic clamp

The purpose of hyperglycaemic clamping is to raise the blood glucose level to a fixed plateau and maintain the plateau for at least one hour to observe a steady-state blood glucose concentration. The investigators intend to perform the hyperglycaemic clamping procedure one time in all 14 patients following an overnight fast and aim for a fixed blood glucose level above 8 mmol/L. The patient will have an arterial line placed in the radial artery, a retrograde catheterization of the jugular bulb and a venous line for infusions of glucose, potassium, and isotonic saline. To maintain potassium levels at wanted levels, an isotonic saline solution containing potassium will be infused continuously and arterial samples of potassium and glucose will be measured at minimum every 10 minutes from the start of the intervention.

干预措施: Hyperglycaemic clamp

结局指标

主要结局

(Change in) MD-glucose (mmol/L)

时间窗: Throughout the intervention, approximately five hours

Change in) MD-glucose (mmol/L) over time as a function of (a set change in) arterial blood glucose (mmol/L)

次要结局

  • Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.(Throughout the intervention, approximately five hours)
  • Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.(Throughout the intervention, approximately five hours.)

研究点 (2)

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