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临床试验/NCT03095742
NCT03095742已完成不适用

Bedside Monitoring of Cerebral Energy State During the Peri-cardiac Arrest Period - Blood Pressure Targets in Post Resuscitation Care

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
LP ratio

研究概览

简要总结

In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%, and the total mortality, although improved substantially over the last decade, remain to be significant, in most countries at up to 90%. An adequate blood pressure must be maintained in the post-cardiac arrest patient and helps to avoid further brain injury. The current trial addresses strategies for neuroprotection using a design of two different target blood pressure levels. "Normal MAP" (approximately 65 mmHg) vs. "high MAP" (approximately 75 mmHg). Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive resuscitation, and reflecting the metabolic changes after successful resuscitation are urgently needed to enable a more personalized resuscitation and post resuscitation care.

It is technically simple and feasible to place a microdialysis catheter in the jugular bulb and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio obtained from microdialysis of cerebral venous blood may be a sensitive indicator of impending cerebral damage and might play a critical role in detecting the early responses of post resuscitation care. Aim of this study is to investigate the global cerebral metabolic changes during CA and post-resuscitation care.

详细描述

Microdialysis assessment of cerebral energy state during cardiac arrest and cardiopulmonary resuscitation in humans

In comatose patients resuscitated from out of hospital cardiac arrest (OHCA), neurological injuries remain the leading cause of death. The in-hospital mortality is reported at 30-50%, and the total mortality, although improved substantially over the last decade, remain to be significant, in most countries at up to 90%. The brain of a patient resuscitated after cardiac arrest (CA) may have suffered ischemia and when spontaneous circulation is re-established, the subsequent reperfusion may cause further damage. Brain ischemia and the reperfusion injury lead to tissue degeneration and loss of neurological function, the extent dependent on duration and density of the insult. Temperature control and Targeted Temperature Management (TTM) targeting 33-36°C may mitigate this damage and is recommended in current international guidelines. However, managing post cardiac arrest patients are much more complicated than TTM alone, and blood pressure measurements and mechanical ventilation as part of post resuscitation care is emphasized. An adequate blood pressure must be maintained in the post-cardiac arrest patient. Episodes of hypotension can cause secondary injury, in addition to any initial insult incurred during the arrest by the brain and other organs. Mean arterial blood pressure (MAP) should be above 65 mmHg to reverse the acute shock state, and may preferably 80 to 100 mmHg to optimize cerebral perfusion. When determining blood pressure goals, clinicians must balance the metabolic needs of an ischemic brain with the potential for overstressing a decompensated heart. Cerebral autoregulation is often impaired after cardiac arrest, and brain perfusion declines when the MAP falls below 80 to 100 mmHg. Thus, maintaining an adequate MAP helps to avoid further brain injury. However, blood pressure goals have not been investigated in prospective clinical trials, and remain to be based on observational data and extrapolation from experimental data. While experimental studies suggest that high mean blood pressure targets are needed for maintaining cerebral blood flow, registries on consecutive clinical cases undergoing post resuscitation care suggest that lower blood pressure targets are used in clinical practice. But data RCT´s addressing specific targets in post resuscitation care have not been performed. The current trial addresses these strategies for neuroprotection in using design of two different target blood pressure levels. Intervention: 1:1 randomization:

"Normal MAP" (approximately 65 mmHg) vs. "high MAP" (approximately 75 mmHg) Markers measuring global cerebral ischemia caused by cardiac arrest and consecutive resuscitation, and reflecting the metabolic changes after successful resuscitation are urgently needed to enable a more personalized resuscitation and post resuscitation care.

It is technically simple and feasible to place a microdialysis catheter in the jugular bulb and monitor biochemical variables related to cerebral energy metabolism bedside. The LP ratio obtained from microdialysis of cerebral venous blood may be a sensitive indicator of impending cerebral damage and might play a critical role in detecting the early responses of post resuscitation care. Aim of this study is to investigate the global cerebral metabolic changes during CA and post-resuscitation care.

Aim: The study aim to (I) investigate whether the LP ratio obtained by microdialysis (MD) of the cerebral venous outflow reflects a derangement of global cerebral energy state during the peri-cardiac arrest period and (II) investigate the correlation between LP ratio and neurological outcome among patients with cardiac arrest and (III) investigate the correlation between LP ratio and the randomized blood pressure targets.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Interventions are considered emergency procedures and study blood pressure measurement using the study blood pressure modules should be commenced as soon as possible after sustained ROSC, screening and randomisation. Study target blood pressure will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years
  • Out-of-hospital cardiac arrest (OHCA)
  • Presumed cardiac cause
  • Unconsciousness (Glasgow Coma Score ≤8)
  • Sustained return of spontaneous circulation (ROSC) (20 minutes of circulation)
  • Target temperature management is indicated

排除标准

  • Conscious patients
  • Pregnancy
  • OHCA of presumed non-cardiac cause
  • Cardiac arrest after arrival in hospital
  • Known bleeding diathesis
  • Suspected or confirmed acute intracranial bleeding
  • Suspected or confirmed acute stroke
  • Temperature on admission <30°C
  • Unwitnessed asystole
  • Persistent cardiogenic shock
  • Known limitations in therapy
  • Known disease making 180 day survival unlikely
  • Known pre-arrest cerebral performance category 3 or 4
  • > 240 minutes from ROSC to randomization

结局指标

主要结局

LP ratio

时间窗: Peri-caridac arrest period - 72 hours

Analysis will compare the two target blood pressure groups with respect to lactate/pyruvate (LP) ratio.

次要结局

  • CPC(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simon Mölström

MD

Odense University Hospital

研究点 (2)

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