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临床试验/NCT07316634
NCT07316634尚未招募不适用

Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery: A Single-Center Prospective Observational Cohort Study

Beijing Anzhen Hospital0 个研究点目标入组 1,200 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,200
主要终点
Incidence of the composite endpoint of adverse events within 30 days postoperatively

研究概览

简要总结

In patients after cardiac surgery, disturbances in macrocirculatory fluctuations and tissue perfusion commonly coexist. The stress state induced by factors such as surgical manipulation, cardiopulmonary bypass, anesthetic agents, pain, and ischemia-reperfusion injury, along with the use of vasoactive drugs postoperatively, often leads to increased blood pressure fluctuations in the early postoperative period. Additionally, dysregulation of organ blood flow autoregulation post-surgery contributes to peripheral circulatory impairment, rendering perfusion pressure an unreliable indicator of actual organ perfusion. We aim to assess postoperative blood pressure fluctuation using blood pressure variability and evaluate peripheral circulatory status via the perfusion index. In this prospective cohort study, we will examine the correlation between these two parameters and perioperative adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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 at surgery ≥ 18 years
  • Patients admitted to the ICU for the first time after undergoing their first cardiac surgical procedure during the current hospitalization ③ Expected to receive continuous invasive blood pressure monitoring and noninvasive pulse oximetry monitoring for at least 12 hours postoperatively in the ICU ④ Written or verbal informed consent obtained from the patient or their family members

排除标准

  • Patients with severe peripheral vascular disease in the arm used for noninvasive pulse oximetry monitoring
  • Patients not undergoing invasive hemodynamic monitoring ③ Patients requiring preoperative or intraoperative support with IABP or ECMO
  • Patients expected to have incomplete postoperative monitoring data or a monitoring duration of less than 12 hours
  • Postoperative patients who are not admitted to the ICU for the first time during the current hospitalization ⑥ Patients admitted to the ICU prior to undergoing cardiac surgery ⑦ Patients with critically insufficient baseline preoperative data

研究组 & 干预措施

Adult Patients After Cardiac Surgery

干预措施: Blood Pressure Variability and Perfusion Index (Other)

结局指标

主要结局

Incidence of the composite endpoint of adverse events within 30 days postoperatively

时间窗: Within 30 days after surgery

Total incidence of death, stroke, perioperative myocardial infarction, infection, reoperation, and continuous renal replacement therapy. Diagnostic criteria: Stroke was characterized by a new focal deficit associated with a compatible image on computed tomography. Perioperative myocardial infarction was diagnosed when cardiac troponin I shows an acute change with at least one value exceeding the 99th percentile upper reference limit, along with one of the following: new pathologic Q waves, imaging evidence of coronary artery occlusion, or imaging evidence of new loss of viable myocardium. Infection was considered if one of the following diagnoses was made by an Infectious Disease specialist who followed specific protocols: 1) Pneumonia; 2) Catheter related blood stream infection; 3) Sternal wound infection or osteomyelitis.

次要结局

  • Incidence of low cardiac output syndrome within 30 days postoperatively.(Within 30 days after surgery)
  • Incidence of acute respiratory distress syndrome within 30 days postoperatively(Within 30 days after surgery)
  • Incidence of acute kidney injury within 30 days postoperatively.(Within 30 days after surgery)
  • Incidence of prolonged ventilation (>24 hours) within 30 days postoperatively.(Within 30 days after surgery)
  • Length of intensive care unit stay(Within 30 days after surgery)
  • Incidence of new-onset atrial arrhythmias within 30 days postoperatively.(Within 30 days after surgery)

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nan Liu

head of department

Beijing Anzhen Hospital

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