Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult patients undergoing cardiac surgery at Beijing Anzhen Hospital, Capital Medical University

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood Pressure Variability and Perfusion Index

    Other intervention

    All patients in this cohort will undergo invasive hemodynamic monitoring and noninvasive pulse oximetry, postoperative 24-hour blood pressure variability (from minute-to-minute invasive arterial pressure data) and perfusion index (from half-hourly recordings) were obtained through these monitoring modalities.

Treatment groups

1,200 Participants
are divided into 1 treatment group
Group A: Adult Patients After Cardiac Surgery1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Within 30 days after surgery

Secondary outcomes

1

Incidence of low cardiac output syndrome within 30 days postoperatively.

Diagnostic criteria: Cardiac index \< 2.0 L/min/m².

Time frame
Within 30 days after surgery
2

Incidence of acute kidney injury within 30 days postoperatively.

Diagnostic criteria are based on the KDIGO guidelines.

Time frame
Within 30 days after surgery
3

Incidence of acute respiratory distress syndrome within 30 days postoperatively

Diagnostic criteria are based on the 2012 Berlin definition of ARDS.

Time frame
Within 30 days after surgery
4

Incidence of new-onset atrial arrhythmias within 30 days postoperatively.

Diagnostic criteria: atrial fibrillation or atrial flutter lasting more than 1 hour on continuous electrocardiographic monitoring, requiring pharmacological or electrical cardioversion.

Time frame
Within 30 days after surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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