Evaluating Perioperative Interventions to Improve Patient outComes (EPIC-2): BNP Evaluation Before Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Raised natriuretic peptide
研究概览
简要总结
A prospective, multi-centre, observational study of preoperative natriuretic peptide testing for patients undergoing non-cardiac surgery conducted over four weeks.
详细描述
Identification of high-risk surgical patients requires risk stratification. Current clinical risk stratification tools, e.g. Revised Cardiac Risk Index (RCRI), only have a moderate ability to identify these patients. International guidelines, like Canadian Cardiovascular Society on perioperative cardiovascular risk assessment, advocate that all patients 45 yrs and older or patients >18y rs who have significant cardiovascular disease and who are coming for intermediate to high-risk surgery, should get natriuretic peptide (NP) testing. This is because raised preoperative B-type natriuretic peptides have a strong association with postoperative cardiac complications according to observational studies and meta-analyses.
However, in these patients with significant cardiovascular disease coming for intermediate to high-risk surgery it is unknown how many patients will actually have raised B-type natriuretic peptides. That is, which group of patients have an even higher risk in this already high-risk group. Natriuretic peptide (NP) testing is also expensive.
Further identification of patients that need NP testing will reduce costs and focus efforts on those patients who really need it.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 45 years of age.
- •Undergoing intermediate or major non-cardiac surgery requiring an overnight stay in hospital.
- •With at least one of the following criteria:
- •History of ischaemic heart disease or peripheral vascular disease (coronary equivalent)
- •History of stroke or transient ischaemic attack
- •History of congestive cardiac failure
- •Diabetes currently on an oral hypoglycaemic agent or insulin
- •Serum creatinine >175 µmol/L (>2.0mg/dl)
排除标准
- •Patient refusal to participate.
- •Patients presenting for cardiac and obstetric or emergency surgery.
结局指标
主要结局
Raised natriuretic peptide
时间窗: preoperative
Determine the prevalence of abnormal (raised) NP in patients with clinical risk criteria.
次要结局
- Risk prediction(preoperative)
研究者
Bruce Biccard
Second Chair, Department of Anaesthesia and Perioperative Medicine, Professor
University of Cape Town