LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery: a Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Time perioperative heart rate in target range
研究概览
简要总结
Limiting perioperative tachycardia (aiming for a heart rate <90 beats per minute throughout the perioperative period) using the ultra-short acting beta-blocker landiolol in patients with cardiovascular risk factors undergoing major surgery might lower the incidence of perioperative myocardial injury. Feasibility of the intervention needs to be proven prior to conduction of a larger trial.
详细描述
Despite advances in surgical and anaesthetic techniques, perioperative mortality remains high, even in developed countries. Major complications contributing almost half of all deaths after surgery are major bleeding (17%), myocardial injury after non-cardiac surgery (13%) and sepsis (12%). Myocardial injury after non-cardiac surgery occurs up to 18% in patients >45 years and is associated with a marked increase in 30-day mortality. Additional factors posing patients at risk for perioperative myocardial injury might be autonomic dysfunction, measured as exaggerated heart rate response to exercise or impaired heart rate recovery thereafter, as perioperative tachycardia is associated with perioperative myocaridal injury. The perioperative use of beta-blockers remains controversial, but the newely marketed ultra-short acting and highly cardioselective beta-blocker landiolol offers the opportunity to reduce perioperative heart rate without affecting blood pressure. The intervention (perioperative reduction of heart rate using landiolol) in this specific patient population needs to be proven as feasible prior to conducting a larger scale trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients undergoing elective non-cardiac surgery defined as intermediate or high-risk by the 2022 european society of cardiology (ESC) guidelines
- •surgery performed under general anesthesia;
- •expected length of hospital stay ≥ 24 hours;
- •age ≥ 45 years;
- •at least two of the following risk factors:
- •age ≥ 75 years
- •arterial hypertension;
- •ischemic heart disease (history of myocardial infarction or positive exercise test, current complaint of chest pain considered to be secondary to myocardial ischemia, use of nitrates, pathological Q waves, prior coronary revascularization);
- •history of congestive heart failure;
- •history of cerebrovascular disease;
- •peripheral artery disease;
- •diabetes mellitus;
- •GFR ≤ 59 ml/min pro 1.73 m2;
- •pre-operative NTproBNP > 200 pg/ml;
- •excessive sympathetic outflow as proven by exercise testing:
- •impaired heart rate recovery (≤ 12 bpm within 1 minute after cessation of exercise); OR
- •exaggerated heart rate response (≥ 12 bpm after 3 minutes of unloaded pedalling);
排除标准
- •unable to consent or follow study procedures;
- •absolute contraindications for exercise testing;
- •pregnancy or intention to become pregnant;
- •active cardiac conditions (such as unstable coronary syndromes, decompensated heart failure, significant arrhythmias, severe valvular disease);
- •urgent / emergency surgery;
- •already on β-blocker (within the last 30 days prior to recruitment);
- •contraindication for β-blocker therapy (bradycardia (HR < 55 bpm), hypotension (systolic blood pressure < 100 mmHg), severe peripheral vascular disease, severe asthma, allergy, higher-degree atrioventricular block);
- •severe preoperative anaemia (haemoglobin < 100 g/L) unless there is a plan set up and followed for correction prior to surgery;
- •planned intermediate care or intensive care admission;
- •prior enrolment in this trial.
研究组 & 干预措施
Landiolol
Landiolol will be titrated to keep heart rate below 90 beats per minute during surgery after exclusion of other factors possibly causing tachycardia (such as hypovolaemia or pain). Mean arterial pressure will be kept above 65 millimeters of mercury.
干预措施: Landiolol (Drug)
Usual care
In the usual care group, mean arterial pressure will be maintained above 65 millimeters of mercury. In case of tachycardia, causing reasons (such as hypovolaemia) will be sought and treated.
结局指标
主要结局
Time perioperative heart rate in target range
时间窗: From induction of anaesthesia until discharge from postanaesthetic care unit [percent of time heart rate within target range (<90 beats per minute)]
As a marker of successful intervention, time perioperative heart rate in target range (below 90 beats per minute) will serve as primary outcome. The intervention is considered feasible if the heart rate stays at least 90% of the time within the target range during the perioperative period.
次要结局
- Length of hospital stay(Admission to hospital until discharge from hospital [days])
- Perioperative heart rate(From induction of anaesthesa until discharge from postanaesthetic care unit [heart rate in beats per minute * minutes ])
- Dose of vasopressors(Induction of anaesthesia until discharge from postanaeshetic care unit [mcg per recorded drug])
- Length of postanaesthetic care unit stay(Admission to postanaesthetic care unit until discharge from postanaesthetic care unit [minutes])
- Perioperative myocardial injury(72 hours after surgery)