A Prospective, Multi-centre, Randomised Trial of B-type Natriuretic Peptide Guided Therapy to Improve Clinical Outcomes for Patients Undergoing Non-cardiac Surgery: the BETTER Surgery Pilot Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- A composite of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and re-operation.
研究概览
简要总结
The primary hypothesis of the BETTER pilot trial is that B-type natriuretic peptide (BNP) directed medical therapy prior to noncardiac surgery will be associated with improved cardiovascular outcomes, when compared to standard of care.
详细描述
Study hypothesis and aim. The primary hypothesis of the BETTER Surgery Pilot Trial is that BNP directed medical therapy prior to noncardiac surgery will be associated with improved cardiovascular outcomes, when compared to standard of care. The aim of this pilot trial is to test the feasibility of a preoperative BNP directed medical therapy trial, with the intention of then going onto a large international multicentred RCT.
Primary outcome measure. A composite of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and re-operation.
Secondary outcome measures.
Difference in BNP levels at the time of surgery An analysis of outcomes as a measure of achieved value i.e. the value measured immediately prior to surgery.
Duration of hospital stay Admission to critical care Time to surgery Reoperation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •High risk elective preoperative noncardiac surgical patients who are referred to a preanaesthetic clinic for preoperative risk stratification.
排除标准
- •Patient refusal to participate
- •Where clinical opinion suggests that surgery cannot be postponed for at least 3 to 4 weeks to allow for clinical response to a change in medical therapy
结局指标
主要结局
A composite of 30 day mortality, nonfatal myocardial infarction, nonfatal cardiac arrest, congestive cardiac failure and re-operation.
时间窗: 30 days
次要结局
未报告次要终点
研究者
Bruce Biccard
Head of Perioperative Medicine
University of Cape Town