Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2) Interventional Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This study is designed to assess the feasibility of identifying and administering individualized blood pressure targets early critical illness. Recent literature suggests that individualized targets adapted to cerebral perfusion and autoregulation capacity may improve patient outcomes. In this study, cerebral autoregulation capacity is assessed by simultaneous trending of near-infared spectroscopy and arterial blood pressure for 24 hours, within patients' first 2 days in the ICU. The investigators will assess the feasibility of identifying patients' personal targets, then treating patients according to their personal targets for 48 hours. Clinical outcomes explored will include delirium.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to a critical care unit requiring one or more of the following:
- •Respiratory failure requiring invasive mechanical ventilation with an expected duration >24 hours or
- •Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: i. Dopamine ≥7.5 mcg/kg/min, ii. Dobutamine ≥5 mcg/kg/min, iii. Norepinephrine ≥5 mcg/min, iv. Phenylephrine ≥75 mcg/min, v. Epinephrine at any dose, vi. Milrinone at any dose (if used in conjunction with another agent), vii. Vasopressin ≥0.03 u/min (if used in conjunction with another agent)
- •Presence of an arterial line
排除标准
- •Admission to the ICU > 24 hours
- •Life expectancy <24 hours
- •Primary central nervous system admitting diagnosis (e.g. traumatic brain injury, stroke, subarachnoid haemorrhage, cardiac arrest).
- •Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)
研究组 & 干预措施
Autoregulation-based precision blood pressure management
Blood pressure maintenance based on cerebral oximetry autoregulation measurement.
干预措施: Autoregulation-based precision blood pressure management (Drug)
结局指标
主要结局
Recruitment rate
时间窗: From period of study start to finish, an average of one year.
Target recruitment rate = 1 patient/month
Determine optimal mean arterial pressure target (MAPopt)
时间窗: For 24 hours after enrollment
Aim to determine MAPopt in \>75% of patients within the first 24 hours
Maintain MAP within MAPopt range
时间窗: for 24-72 hours after enrolment
Aim to maintain patients in MAPopt range for \>90% of the time for 48 hours
次要结局
- Correlation between delirium and cerebral autoregulation(Up to day 30 after ICU admission or the day of patient discharge)
- Correlation between delirium and time outside MAPopt(Up to day 30 after ICU admission or the day of patient discharge)
- Exploratory short-term delirium outcomes(Up to day 30 after ICU admission or the day of patient discharge)
研究者
Dr. Gordon Boyd
Clinician-Scientist
Queen's University