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NCT Number: NCT07316634

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

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.

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Key information

Conditions

Cardiac Surgery Intensive Care Treatment Hemodynamics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Blood Pressure Variability and Perfusion Index

Other

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Incidence of low cardiac output syndrome within 30 days postoperatively.

    Time frame: Within 30 days after surgery

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

  2. Incidence of acute kidney injury within 30 days postoperatively.

    Time frame: Within 30 days after surgery

    Diagnostic criteria are based on the KDIGO guidelines.

  3. Incidence of acute respiratory distress syndrome within 30 days postoperatively

    Time frame: Within 30 days after surgery

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

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

    Time frame: Within 30 days after surgery

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

  5. Incidence of prolonged ventilation (>24 hours) within 30 days postoperatively.

    Time frame: Within 30 days after surgery

  6. Length of intensive care unit stay

    Time frame: Within 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Nan Liu Director of the Center for Cardiac Intensive Care, MD, PhD

CONTACT

[email protected]

+8613370103573

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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