PRotocolized vs pErsonalized Blood preSSUre peRi-operative paramEters in Coronary Artery Bypass Grafting Surgery: The PRESSURE CABG Cardiac Surgery Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Re-operation for bleeding
研究概览
简要总结
This study will be a pragmatic, prospective, single-centre, unit-based cluster crossover, open-label registry trial. The cardiac surgical intensive care unit (CSICU) will be cluster assigned to alternating MAP targets in 6-month blocks in a sequence. Additional sites across Alberta may be added, as necessary.
详细描述
Personalized Arm: The target MAP will be defined as +10% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements:
- Pre-operative anesthesia or surgical consultation;
- Other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery;
- Inpatient measurement the night before surgery;
- Pre-anesthetic MAP
The lower and upper safety limits of personalized MAP targets will be 50mmHg and <90mmHg, respectively.
Protocolized Arm: The target MAP will be defined as 65 +/- 5mmHg. Pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician.
In both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the CSICU. As an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. In cases with low bilateral saturations where the anesthesiologist feels low MAP may be the putative mechanism, the investigators will request that MAPs be raised in 5mmHg increments. Following completion of the study protocol, the MAP and/or systolic blood pressure targets will be at the discretion of the most responsible physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •All patients > or = to 18 years of age undergoing non-emergent CABG
排除标准
- •Pre-induction use of intravenous inotrope, vasopressor, or vasodilator
- •Re-operation during the index hospital stay
- •Non-CABG valvular or aortic surgery
- •*Patients with end-stage renal disease or pre-operative AKI (defined as in-hospital increase in creatinine by >50%) will be excluded from the renal outcomes but included in the analysis of secondary outcomes
结局指标
主要结局
Re-operation for bleeding
时间窗: Within 7 days of surgery
re-operation for bleeding
Composite of delirium or AKI
时间窗: within 7 days of surgery
composite of delirium(defined as Intensive care delirium screening checklist score \>=4) or Acute kidney injury (defined as a \>=50% rise in serum creatinine)m
次要结局
- Difference in peak median creatinine levels(Up to the time of hospital discharge, estimated average 5 days)
- IV Vasoactive Support(Up to the time of ICU discharge, , estimated average 2 days)
- Vasoactive support >24hrs(Up to 25 hours post-operatively)
- Length of Stay(Up to the time of ICU discharge, estimated average 2 days)
- Delirium(Through 7 days)
- Renal Outcomes(Up to the time of hospital discharge, estimated average 5 days)
- Chest tube output(Through 48 hours post-op)
- Blood Products(Through 48 hours post-operatively)
- Mechanical Ventilation(Up to the time of ICU discharge, estimated average 4 hours)
- The incidence of Stroke(Up to the time of hospital discharge, estimated average 5 days)