Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Number of Participants With Interoperative Hypotension
研究概览
简要总结
Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
Secondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.
详细描述
The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation.
- •Above referral must be in anticipation of a non-cardiac, non-vascular surgery.
- •Must have been on ACE-Inhibitor therapy for at least six weeks.
排除标准
- •Hypotension (systolic blood pressure < 90 or diastolic blood pressure <60) at the time of preoperative evaluation
- •Uncontrolled Hypertension (systolic blood pressure > 150 or diastolic blood pressure > 95) at the time of preoperative evaluation
- •Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology)
- •Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)
- •Left Ventricular ejection fraction less than 40%
- •Clinical evidence of decompensated heart failure at the time of preoperative evaluation
- •End-stage renal disease
- •Organ transplant surgeries
研究组 & 干预措施
ACEI continuation
Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively
干预措施: ACEI continuation (Drug)
ACEI omission
Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.
干预措施: ACEI omission (Drug)
结局指标
主要结局
Number of Participants With Interoperative Hypotension
时间窗: During anesthesia, an expected average of 3 hours.
Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)
次要结局
- Acute Renal Failure(Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.)
- Older Age Subgroup(During anesthesia, an expected average of 3 hours.)
- Postoperative Hypertension(Arrival in PACU to hospital discharge, an expected average of 4 days.)
- Low Blood Pressure Subgroup(During anesthesia, an expected average of 3 hours.)
- Postoperative Hypotension(Arrival in PACU to hospital discharge, an expected average of 4 days.)