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临床试验/CTRI/2021/01/030199
CTRI/2021/01/030199招募中不适用

The effect of continuation versus withholding angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers on mortality and major adverse cardiovascular events in hypertensive patients undergoing elective non-cardiac surgery: An open-label randomised controlled trial

Dr Satyajeet Misra3 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年4月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
3
主要终点
Composite incidence of 30-day all-cause mortality, major adverse cardiovascular

研究概览

简要总结

The incidence of hypertension is increasing in the population and hypertensive patients routinely present for surgery and anesthesia. Angiotensin converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB)s are commonly prescribed as first line antihypertensive agents to patients suffering from hypertension. These drugs are considered cardio protective and improve long term outcomes. However, patients who continue their ACEI/ARBs during surgery may have significant hypotension due to the effects of anesthesia and such hypotension is often difficult to treat. In addition, hypotension may worsen the postoperative outcomes  and patients may have stroke, sepsis or acute kidney injury. However, withholding these drugs before surgery to minimise the incidence of hypotension and angioneurotic edema is also potentially risky as the continued benefits of cardio protection may be lost and patients may have major adverse cardiovascular events. Until date, there is no clear cut consensus on whether ACEI/ ARBs should be continued or withheld before surgery. Even multiple guidelines have differing recommendations with regards to continuation or withholding of ACEI/ARBs before surgery. Thus, this multi-centric open-label randomised controlled trial will look to address the issue by recruiting approximately 2100 patients, half of whom will be randomised to have their ACEI/ARBs withheld before surgery and the other half randomised to continue their medications on the day of surgery. The primary outcome that this trial will seek to address is the 30-day all cause mortality, incidence of major adverse cardiovascular and non-cardiovascular events in an effort to generate the evidence for best practices in this cohort of patients and address definitively the clinical conundrum that has vexed clinicians for more than two decades now.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •All hypertensive adult patients, 18-70 years, on chronic ACEI/ARB therapy (defined as treatment of more than 3 months or at least 14 days) and undergoing elective major non-cardiac surgery (defined as surgery lasting more than 2 hours and/or with an expected postoperative hospital stay of at least 3 days) will be included in this trial.

排除标准

  • •Patients undergoing emergency surgeries within 48 hours, those with preoperative hyperkalemia (serum potassium > 5.5 mmol/L), patients with severe chronic renal insufficiency or those requiring renal replacement therapy, patients in shock (defined as need for vasoactive drugs to maintain blood pressures before surgery), patients taking ACEI/ARBs for LV dysfunction, and patients with uncontrolled hypertension will be excluded.

结局指标

主要结局

Composite incidence of 30-day all-cause mortality, major adverse cardiovascular

时间窗: 30 days after surgery.

events, and non-cardiovascular events (postoperative acute kidney injury, sepsis, respiratory failure requiring re-intubation, and unplanned ICU admissions due to any cause).

时间窗: 30 days after surgery.

次要结局

  • Episodes of hypotension(Until 24 hours after surgery)
  • Hospital free days(30 days of surgery)
  • Postoperative hyperkalaemia requiring intervention(Till discharge from ICU and/or hospital)
  • Myocardial injury(12/24 hours after surgery)
  • Duration of primary hospital stay(Till discharge from primary hospital)
  • Intraoperative angioneurotic edema(Intraoperative)
  • Duration of ICU stay(Total duration of ICU stay)
  • Cancellation of cases due to rebound hypertension(Preoperative)

研究者

发起方
Dr Satyajeet Misra
申办方类型
Other [self]

研究点 (3)

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