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

NCT07316634 | Not Yet Recruiting DMC

• 1 other identifier: KS2025145
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardiac Surgery Intensive Care Treatment; Hemodynamics

Keywords

Blood Pressure Variability; Perfusion Index; Cardiac Surgery

Outcome Measures

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.

  Within 30 days after surgery

Secondary Outcomes (6)

• Incidence of low cardiac output 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 acute respiratory distress syndrome within 30 days postoperatively

  Within 30 days after surgery

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

  Within 30 days after surgery

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

  Within 30 days after surgery

Study Arms (1)

Adult Patients After Cardiac Surgery

Other: Blood Pressure Variability and Perfusion Index

Interventions

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.

Adult Patients After Cardiac Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Central Study Contacts

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

CONTACT

+8613370103573; ln9102@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of department

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12