Angiotensin-converting Enzyme Inhibitors and Angiotensin Receptor Blockers During the Perioperative Period: to Withdraw or to Continue? A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 342
- 试验地点
- 7
- 主要终点
- Postoperative acute kidney injury
研究概览
简要总结
This is a multicenter randomized clinical trial to determine the effect of continuation versus withdrawal of angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB) in the perioperative period on postoperative complications.
详细描述
Rationale:
Angiotensin inhibitors including angiotensin convertying enzyme inhibitors (ACEI), and angiontensin receptors blockers (ARB) are frequently used to treat patients with chronic hypertension. These drugs reduce morbidity and mortality on the long term. However, when patients who use ACEI or ARB undergo surgery, hypotension may occur in the perioperative period, which may can lead to organ hypoperfusion and damage. On the other hand, when ACEI and ARB are temporarily discontinued in the perioperative period, hypertension may occur which also may lead to complications. Therefore, before surgery the anesthesiologist advises the patient to continue or to temporarily withdraw this drug. Importantly, it is currently unclear which strategy is best, and international guidelines are disconcordant on this point. Policy varies between hospitals and even between anesthesiologists: in some hospitals, patients are advised to temporarily withdraw the ACEI/ARB, whilst in other hospitals patients are advised to continue this drug. The latest research on this topic suggests that perioperative continuation of ACEI/ARB may lead to more complications, but definitive evidence is lacking. Therefore it is important to perform a randomized trial to compare the two options: perioperative continuation versus withdrawal of ACEI/ARB.
Objective:
The objective of this trial is to determine the effect of continuation versus withdrawal of ACEI and ARB in the perioperative period on postoperative complications, expressed as acute kidney injury (AKI), myocardial injury, and quality of life (QoL).
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
- Prevention
- 盲法
- None
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
- •Chronic ACEI or ARB use for the treatment of hypertension. Patients who use a com-bination pill with a diuretic are eligible as well;
- •Scheduled for elective intermediate to high risk noncardiac surgery, defined according to the European Society of Cardiology / European Society of Anesthesiology guidelines on noncardiac surgery;
- •Expected postoperative length of stay of at least two days.
排除标准
- •Severe chronic kidney disease, defined as GFR<30 ml/min/1.73 m2;
- •ACEI/ARB use for the treatment of chronic systolic heart failure, defined as left ven-tricular ejection fraction ≤40%;
- •ACEI/ARB use within one year after ST-elevated myocardial infarction, according to the fourth universal definition of myocardial infarction;
- •Transplant surgery;
- •ACEI/ARB use in a combination pill together with a drug other than a diuretic, including calcium channel blockers, beta-blockers and neprilysin inhibitors;
- •Use of drugs acting on the renin-angiotensin-aldosterone system other than ACEI/ARB, e.g. aliskiren.
研究组 & 干预措施
Intervention group
Perioperative withdrawal of ACEI/ARB.
干预措施: Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers (Drug)
Intervention group
Perioperative withdrawal of ACEI/ARB.
干预措施: Blood draw (Diagnostic Test)
Intervention group
Perioperative withdrawal of ACEI/ARB.
干预措施: Diary to register drug adherence (Behavioral)
Intervention group
Perioperative withdrawal of ACEI/ARB.
干预措施: Quality of life questionnaire (Behavioral)
Intervention group
Perioperative withdrawal of ACEI/ARB.
干预措施: WHODAS questionnaire (Behavioral)
Control group
Perioperative continuation of ACEI/ARB.
干预措施: Blood draw (Diagnostic Test)
Control group
Perioperative continuation of ACEI/ARB.
干预措施: Diary to register drug adherence (Behavioral)
Control group
Perioperative continuation of ACEI/ARB.
干预措施: Quality of life questionnaire (Behavioral)
Control group
Perioperative continuation of ACEI/ARB.
干预措施: WHODAS questionnaire (Behavioral)
结局指标
主要结局
Postoperative acute kidney injury
时间窗: Within two days after surgery
Postoperative acute kidney injury, defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guideline.
次要结局
- Postoperative myocardial injury(Within two days after surgery)
- Length of stay(Within three months after surgery)
- Kidney function loss(Within three months after surgery)
- Acute postoperative myocardial injury(Within two days after surgery)
- Intraoperative hypotension(From the start of anesthesia until the end of surgery)
- Postoperative hypotension(From the end of surgery up to and including the second postoperative day)
- Preoperative hypertension(Within 24 hours before start of anesthesia)
- Postoperative hypertension(From the end of surgery up to and including the second postoperative day)
- Acute kidney function loss(Within two days after surgery)
- Mortality(Within three months after surgery)
- Quality of life(At three months after surgery)
- End-stage renal disease(Within three months after surgery)
- Major cardiovascular complications(Within three months after surgery)
- Disability(At three months after surgery)
研究者
Judith van Waes
J.A.R. van Waes, MD PhD
UMC Utrecht