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临床试验/NCT07511101
NCT07511101已完成不适用

Risk Factors for Perioperative Hypotension After Abdominal Aortic Aneurysm Repair and Its Impact on Early Survival

Rijnstate Hospital1 个研究点 分布在 1 个国家目标入组 511 人开始时间: 2023年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
511
试验地点
1
主要终点
30-day survival

研究概览

简要总结

Background: An abdominal aortic aneurysm (AAA) is a localized dilatation of the infrarenal aorta that, when it meets critical criteria, can rupture and cause a vital emergency, requiring immediate surgery with a mortality rate close to 85%(1). Also, symptomatic AAA and/or imminent rupture is a surgical emergency that should be recognized and treated promptly. Elective procedures are usually performed in patients with AAA with a diameter greater than 5.5 cm in men and 5.0 cm in women(2,3).

There are different techniques for the surgical repair of AAA, which are divided into two main groups: endovascular and open procedures. The endovascular procedure offers an early survival benefit, better postoperative recovery, and fewer incision-related complications as it is a minimally invasive procedure. However, it requires more re-interventions, but most are mainly minor endovascular procedures. In contrast, an open approach has a better 15-year late survival benefit, associated with greater graft durability, a lower rate of re-interventions, and the additional advantage of being more affordable (4-7).

Several risk factors have been established around surgical procedures that may affect the outcome, including preoperative and intraoperative hypotension. Preoperative hypotension is one of the most crucial factors, especially when talking about ruptured AAA, where it is present with a high frequency and has been seen as an association with mortality with an AOR of 3.28 (CI 1.75-5.41; P < .001) (8). For intraoperative hypotension, a study showed that it increased the 30-day mortality after an elective open repair of AAA with an OR of 6.61 (CI 0.71-61.07; p = 0.05). Also, it has been associated with liver dysfunction (p < 0.001) and colonic ischemia (P=0.021) (9-11).

However, the frequency and effects of postoperative hypotension in open and endovascular AAA surgery have not been described in the literature despite the everyday use of vasopressor medications (48%) in the immediate medical management following an open AAA repair(12). However, other studies have shown that postoperative hypotension in abdominal surgery is a significant complication that can have adverse effects on the patient. This condition is characterized by a decrease in blood pressure, which can lead to myocardial injury, acute kidney damage, and an increase in short-term mortality(13).

According to literature, postoperative hypotension is common after major abdominal surgeries, and its detection may be suboptimal if routine vital sign assessments are the sole monitoring method. A prospective observational study found that nearly one-quarter of patients experienced episodes of mean arterial pressure (MAP) below 70 mmHg for at least 30 minutes, many of which went undetected through routine evaluations(14). Another study highlighted that prolonged postoperative hypotension, defined by absolute MAP thresholds, is associated with myocardial injury, especially when MAP falls below 65 mmHg for extended periods (15).

In addition, in other vascular interventions like carotid endarterectomy, postoperative hypotension has been associated with increased risks of 30-day mortality, stroke, myocardial infarction, and length of stay(16).

Given the potential implications for adverse perioperative outcomes, it is essential to elucidate potential risk factors to tailor the perioperative management of AAA repair further. Thus, we aim to describe the mortality and determine the risk factors associated with peroperative and postoperative hypotension at 48 hours in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 1-1-2013 until 31-12-2021.

Research question: What were the risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 to 2021?

Hypothesis:

Alternate hypothesis: There are specific risk factors associated with postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital during the period 2013 until 2021.

详细描述

Research design: Observational, monocenter, retrospective cohort study.

Selection Criteria:

  • Inclusion criteria: all patients treated open and endovascular for an abdominal aortic aneurysm in Rijnstate between 1-1-2013 and 31-12-2021.
  • Exclusion criteria: Patients managed hybrid (EVAR + open) or expectantly.

Objectives:

General Objective: Determine the risk factors associated with per- and postoperative hypotension in patients who underwent an Infrarenal Abdominal Aortic Aneurysm Repair at the Rijnstate Hospital from 1-1-2013 until 31-12-2021.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years
  • Elective AAA repair between 2013 and 2022 (endovascular and open)

排除标准

  • Data from the blood pressure monitoring system were only available from 2013, so patients treated before January 1th 2013 were excluded.
  • Patients were also excluded from the study if registered objection to use their data for research,
  • absence of blood pressure data,
  • revision surgery after previous endovascular or open repair,
  • ruptured aneurysm,
  • mycotic aneurysm, or
  • treatment with endovascular aneurysm sealing.

研究组 & 干预措施

non-complex AAA repair

Patients treated with standard EVAR

Complex AAA repair

Patients treated by complex endovascular or open AAA repair

结局指标

主要结局

30-day survival

时间窗: 30 days

30-day survival

次要结局

  • 1-year survival(1-year)
  • Prevalence intra-operative hypotension(peri-operative)
  • Prevalence post-operative hypotension(until 48 hours post-operatively)

研究者

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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