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临床试验/NCT05416944
NCT05416944已完成不适用

Effect of Personalized Perioperative Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Having Major Abdominal Surgery: a Multicenter Prospective Randomized Controlled Interventional Clinical Trial

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 1,272 人开始时间: 2023年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,272
试验地点
2
主要终点
Composite outcome of major postoperative complications

研究概览

简要总结

Rates of major complications and mortality in the first weeks after surgery remain very high: postoperative mortality is still around 2% in central Europe and the United States. Postoperative deaths are a consequence of postoperative complications. Postoperative complications that are most strongly associated with postoperative death include acute kidney injury and acute myocardial injury. To avoid postoperative complications it is thus crucial to identify and address modifiable risk factors for complications. One of these modifiable risk factors may be intraoperative hypotension. Intraoperative hypotension is associated with major postoperative complications including acute kidney injury, acute myocardial injury, and death. It remains unknown which blood pressure value should be targeted in the individual patient during surgery to avoid physiologically important intraoperative hypotension. In current clinical practice, an absolute mean arterial pressure threshold of 65mmHg is used as a lower "one-size-fits-all" intervention threshold. This "population harm threshold" is based on the results of retrospective studies. However, using this population harm threshold for all patients ignores the obvious fact that blood pressure varies considerably among individuals. In contrast to current "one-size-fits-all" perioperative blood pressure management, the investigators propose the concept of personalized perioperative blood pressure management. Specifically, the investigators propose to test the hypothesis that personalized perioperative blood pressure management reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, and death within 7 days after surgery compared to routine blood pressure management in high-risk patients having major abdominal surgery. The investigators will perform preoperative automated blood pressure monitoring for one night to define individual intraoperative blood pressure targets. Automated blood pressure monitoring is the clinical reference method to assess blood pressure profiles. The mission of the trial is to reduce postoperative morbidity and mortality after major surgery. The vision is to achieve this improvement in patient outcome by using the innovative concept of personalized perioperative blood pressure management. This trial is expected to change and improve current clinical practice and will have a direct impact on perioperative blood pressure management guidelines.

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
Single (Participant)

盲法说明

In patients in the routine management group, the treating anesthesiologists will be blinded to data of preoperative automated blood pressure monitoring to avoid performance bias. Participants are blinded to group allocation.

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

  • Consenting patients ≥45 years scheduled for elective major abdominal surgery under general anesthesia that is expected to last ≥90 minutes AND
  • Presence of ≥1 of the following high-risk criteria:
  • exercise tolerance <4 metabolic equivalents as defined by the guidelines of the American College of Cardiology/American Heart Association
  • renal impairment (serum creatinine ≥1.3 mg/dL or estimated glomerular filtration rate <90 mL/min/1.73 m2 within the last 6 months)
  • coronary artery disease (any stage)
  • chronic heart failure (New York Heart Association Functional Classification ≥II)
  • valvular heart disease (moderate or severe)
  • history of stroke
  • peripheral arterial occlusive disease (any stage)
  • chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any stage)
  • diabetes mellitus requiring oral hypoglycemic agent or insulin
  • immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma, solid organ cancer) or therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above Cushing threshold])
  • liver cirrhosis (any Child-Pugh class)
  • body mass index ≥30 kg/m2
  • current smoking or 15 pack-year history of smoking
  • age ≥65 years
  • expected anesthesia duration >180 minutes
  • B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic peptide (NT-proBNP) >200 ng/L within the last 6 months

排除标准

  • emergency surgery
  • surgery: nephrectomy, liver or kidney transplantation
  • status post transplantation of kidney, liver, heart, or lung
  • sepsis (according to current Sepsis-3 definition)
  • American Society of Anesthesiologists physical status classification V or VI
  • pregnancy
  • patients on renal replacement therapy
  • impossibility of preoperative automated blood pressure monitoring

结局指标

主要结局

Composite outcome of major postoperative complications

时间窗: Postoperative Day 7

Collapsed composite ("any event versus none") of acute kidney injury, acute myocardial injury (including myocardial infarction), non-fatal cardiac arrest, and death within 7 days after surgery

次要结局

  • Composite outcome of major postoperative complications(Postoperative Day 3)
  • Postoperative acute myocardial injury (including myocardial infarction)(Postoperative Day 7)
  • Postoperative non-fatal cardiac arrest(Postoperative Day 90)
  • Postoperative infectious complications(Postoperative Day 7)
  • Postoperative acute kidney injury(Postoperative Day 7)
  • Postoperative neurological infection(Postoperative Day 7)
  • Postoperative urinary system infection(Postoperative Day 7)
  • Postoperative unknown infection with pathogenic organisms in tissue or fluid(Postoperative Day 7)
  • Postoperative death(Postoperative Day 90)
  • Composite outcome of long-term postoperative complications(Postoperative Day 90)
  • Postoperative need for renal replacement therapy(Postoperative Day 90)
  • Postoperative fever(Postoperative Day 7)
  • Postoperative respiratory infection(Postoperative Day 7)
  • Postoperative colitis or infection with Clostridium difficile(Postoperative Day 7)
  • Postoperative endometritis(Postoperative Day 7)
  • Postoperative organ or space surgical site infection(Postoperative Day 7)
  • Postoperative myocardial infarction(Postoperative Day 90)
  • Postoperative surgical site infection(Postoperative Day 7)
  • Postoperative deep incisional surgical site infection(Postoperative Day 7)
  • Postoperative sepsis(Postoperative Day 7)
  • Hospital discharge(Postoperative Day 90)
  • Unplanned hospital re-admission(Postoperative Day 30)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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