Cardiac Surgery Intensive Care TreatmentNCT07316634
Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery
An observational study of Cardiac Surgery Intensive Care Treatment and Hemodynamics, run by Beijing Anzhen Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery Intensive Care Treatment, Hemodynamics
- What is being tested?
- Blood Pressure Variability and Perfusion Index
- How many people
- 1,200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Aug 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing cardiac surgery at Beijing Anzhen Hospital, Capital Medical University
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Nan Liu Director of the Center for Cardiac Intensive Care, MD, PhD contact
About this study
Official title: Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery: A Single-Center Prospective Observational Cohort Study
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.
- Being tested
- Blood Pressure Variability and Perfusion Index
- Keywords
- Blood Pressure Variability, Perfusion Index, Cardiac Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure Variability and Perfusion IndexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult Patients After Cardiac Surgery | Not described Receives: Other: Blood Pressure Variability and Perfusion Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (6)
Incidence of low cardiac output syndrome within 30 days postoperatively.
Diagnostic criteria: Cardiac index < 2.0 L/min/m².
Measured: Within 30 days after surgery
Incidence of acute kidney injury within 30 days postoperatively.
Diagnostic criteria are based on the KDIGO guidelines.
Measured: Within 30 days after surgery
Incidence of acute respiratory distress syndrome within 30 days postoperatively
Diagnostic criteria are based on the 2012 Berlin definition of ARDS.
Measured: Within 30 days after surgery
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.
Measured: Within 30 days after surgery
Incidence of prolonged ventilation (>24 hours) within 30 days postoperatively.
Measured: Within 30 days after surgery
Length of intensive care unit stay
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery Intensive Care TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Liu, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316634
- Sponsor's protocol ID
- KS2025145
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postoperative Blood Pressure Variability, Perfusion Index and Perioperative Adverse Events in Cardiac Surgery: A Single-Center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07316634
- Acronym / sponsor ID
- KS2025145
- Keywords
- Blood Pressure Variability, Perfusion Index, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Patients After Cardiac Surgery | – | Other: Blood Pressure Variability and Perfusion Index |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing cardiac surgery at Beijing Anzhen Hospital, Capital Medical University
Key inclusion criteria (2 listed)
- Age at surgery ≥ 18 years
Key exclusion criteria (4 listed)
- Patients with severe peripheral vascular disease in the arm used for noninvasive pulse oximetry monitoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Pressure Variability and Perfusion IndexAll 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. | Other | Adult Patients After Cardiac Surgery |
Primary outcome
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.
6 secondary outcomes
Incidence of low cardiac output syndrome within 30 days postoperatively.
Time frame: Within 30 days after surgery
Incidence of acute kidney injury within 30 days postoperatively.
Time frame: Within 30 days after surgery
Incidence of acute respiratory distress syndrome within 30 days postoperatively
Time frame: Within 30 days after surgery
Incidence of new-onset atrial arrhythmias within 30 days postoperatively.
Time frame: Within 30 days after surgery
Incidence of prolonged ventilation (>24 hours) within 30 days postoperatively.
Time frame: Within 30 days after surgery
Length of intensive care unit stay
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nan Liu Director of the Center for Cardiac Intensive Care, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery Intensive Care Treatment and Hemodynamics, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nan Liu Director of the Center for Cardiac Intensive Care, MD, PhD (+8613370103573, ln9102@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the composite endpoint of adverse events within 30 days postoperatively (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.