Goal-Directed Therapy (GDT) Using Hypotension Prediction Index (HPI) Following Cardiac Surgery: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 24-hour cumulative IV fluid administration
研究概览
简要总结
Pilot prospective randomized control trial comparing goal-directed therapy algorithm vs routine care in the intensive care unit following cardiac surgery.
详细描述
Rationale:
Goal-directed therapy (GDT) has been shown to reduce complications and length of stay on cardiac surgery patients. Unfortunately, the existing literature on GDT in CV surgery has several limitations, which creates uncertainty over the expected benefit of implementing this care element with high associated costs and impact on workflow. Hypotension Prediction Index (HPI) is a proprietary algorithm that utilizes pulse contour analysis from invasive arterial pressure monitoring to identify patients at risk for becoming hypotensive within 15 minutes. The algorithm was developed using machine learning on a large surgical/ICU data set, and then externally validated on non-cardiac and cardiac surgical patients. HPI, as part of a GDT algorithm, may allow healthcare providers to identify patients recovering from cardiac surgery who may benefit from optimization prior to becoming hypotensive and assist with selecting the most appropriate hemodynamic intervention.
Hypothesis:
Application of an HPI-based GDT algorithm will result in a difference in cumulative fluid administration over the first 24-hours of index ICU admission following cardiac surgery.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Planned cardiac surgery using cardiopulmonary bypass (sternotomy or MICS)
- •Preoperative European System for Cardiac Operative Risk Evaluation II (EuroSCORE II) of 2% or more.
- •Informed consent obtained.
排除标准
- •Emergency surgery
- •Patients who refuse participation
- •Patients who are unable to give informed consent
- •Patients who are having a heart or lung transplant.
- •Surgery for insertion of any ventricular assist device
- •Aortic arch procedures with any degree of debranching or hybrid with endovascular intervention in the ascending aorta +/- arch.
- •Patients who require MCS (including ECMO, Impella, or IABP) post-operatively
- •Patients on contact/droplet isolation.
- •Patients deemed excessively unstable and/or complex by their attending intensivist on arrival to the ICU.
- •If the post-operative arterial line MAP goal is not 65 mmHg.
- •Patients who suffer intra-operative mortality.
研究组 & 干预措施
Control
Routine post-operative clinical care.
Intervention
Goal-directed therapy algorithm in addition to routine post-operative clinical care.
干预措施: Goal-directed therapy (Device)
结局指标
主要结局
24-hour cumulative IV fluid administration
时间窗: 24-hours
Cumulative post-operative intravenous fluid administration over the first 24-hours of index ICU admission.
次要结局
- Study Protocol Compliance(1-year)
- Arterial Monitoring Reliability(1-year)
- Mobilization(Index admission, up to 30-days)
- Hydration(Index admission, up to 30-days)
- Mortality(Up to 1-year post-operative)
- Nutrition(Index admission, up to 30-days)
- Patient-centered Outcome(30-days)
- Re-admission(30-days)
- Mobilzation(Index admission, up to 30-days)
- Length of Stay(Up to 1-year post-operative)
- Fluid Administration(Duration of ICU stay, up to 30-days)
- Vasoactive medication administration(Duration of ICU stay, up to 30-days)
- Hemodynamic parameters(48-hours or when arterial line removed)
- Enrollment(1-year)
- GDT algorithm compliance(48-hours or when arterial line removed)
- End-organ dysfunction/injury(Index admission, up to 30-days)
- Transfusion(Index admission, up to 30-days)