Short-Stay Intensive Care for Coronary Artery Bypass Patients,Development of a Guideline for Giving Adequate Care on the Cardiosurgical Intensive Care
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 597
- 试验地点
- 2
- 主要终点
- Intensive Care (IC) readmissions
研究概览
简要总结
Objective: To evaluate the safety and cost-effectiveness of Short Stay Intensive Care (SSIC) treatment for low-risk coronary artery bypass patients Design: Randomized clinical equivalence trial Setting: University Hospital Maastricht, the Netherlands Patients: low-risk coronary artery bypass patients Interventions: 600 patients were randomly assigned to undergo either SSIC treatment (8 hours Intensive Care) or control treatment (care as usual, overnight Intensive Care).
Measurements: The primary outcome measures were Intensive Care (IC) readmissions and total hospital stay. The secondary outcome measures were total hospital costs, Quality of Life (QoL), postoperative morbidity and mortality. Hospital costs consisted of the cost of hospital admission(s) and outpatient costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Coronary artery bypass patients
排除标准
- •age older than 78 years,
- •ejection fraction of less than 30%
- •stage 3 obesity (BMI>40kg/m2)
- •haemodialysis (kidney replacing therapy)
- •pulmonary hypertension (systolic <40mmHg)
- •recent CVA (<1month)
- •recent myocardial infarction (<24hours)
- •cardiogenic shock, (systolic blood pressure<80mmHg,
- •central filling pressure>20mmHg,
- •cardiac index<1.8 litres/minute/m2),
- •need for inotropic therapy (>5mg/mcg/min. dopamine or dobutamine)
- •ongoing infarction (a significant increase of enzyme "CKMB" within 4 hours before surgery)
- •the need for intra-aortic balloon pump
- •inability to give informed consent
- •inability to speak/ read/ understand the Dutch language
- •patients who had emergency surgery.
结局指标
主要结局
Intensive Care (IC) readmissions
时间窗: one month postoperative
次要结局
- total hospital stay, total hospital costs, postoperative morbidity and mortality(one month)
- generic and disease specific Quality of Life (QoL)(one year postoperative)