Cardiac SurgeryNCT07324694
Impact of Intraoperative Hemodynamic Instability on Outcomes in Cardiac Surgery
An observational study of Cardiac Surgery and Intraoperative Hemodynamic Instability, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication
- How many people
- 351 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Apr 2025to 20 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 elective cardiac surgery with cardiopulmonary bypass at a tertiary care university hospital.
Who may be able to join
- Patients aged 18 years or older.
- Scheduled for elective cardiac surgery (CABG, Valve replacement/repair, or combined procedures).
- Surgery performed under cardiopulmonary bypass (CPB).
- Preoperative sinus rhythm.
- Signed informed consent form.
Who cannot join
- Emergency or salvage surgery.
- Off-pump coronary artery bypass grafting.
- Preoperative mechanical circulatory support (IABP, ECMO) requirement.
- Pre-existing chronic renal failure requiring dialysis (HD/PD).
- Pre-existing cognitive impairment, dementia, or history of psychiatric disorders affecting cooperation.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi Yaşargil Training and Research Hospital
Diyarbakır, Diyarbakır, 21070
About this study
Official title: Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study
Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP < 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.
Read the detailed description
Hemodynamic instability during cardiac surgery is a critical factor influencing postoperative recovery. While transient hypotension is common, prolonged instability may lead to end-organ damage due to hypoperfusion. This prospective observational study will be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital.
Patients scheduled for elective cardiac surgery (Coronary Artery Bypass Grafting, Valve replacement/repair, or combined procedures) utilizing cardiopulmonary bypass will be enrolled. Intraoperative hemodynamic data, including Mean Arterial Pressure (MAP), heart rate, and vasoactive medication requirements, will be recorded.
Patients will be categorized into two groups based on intraoperative stability:
- Hemodynamic Instability Group: Patients experiencing MAP < 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure.
- Stable Group: Patients maintaining hemodynamic stability without significant hypotensive episodes.
The primary endpoint is a composite of major adverse events within 30 days, including Postoperative Delirium (assessed via CAM-ICU), Acute Kidney Injury (KDIGO criteria), Stroke, and All-cause Mortality. Secondary endpoints include the duration of mechanical ventilation and length of ICU/hospital stay. The study aims to provide evidence-based thresholds for intraoperative blood pressure management to improve patient outcomes.
- Conditions
- Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Acute Kidney Injury, Postoperative Delirium (POD)
- Keywords
- Intraoperative Hypotension, Cardiopulmonary Bypass, Mean Arterial Pressure, Cohort Study
- Medical subject headings
- Postoperative Complications, Acute Kidney Injury, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic Instability Group | Patients who exhibit intraoperative hemodynamic instability, defined as Mean Arterial Pressure (MAP) < 65 mmHg for >5 minutes continuously, or requiring vasopressor/inotropic support to maintain MAP. | |
| Hemodynamically Stable Group | Patients who maintain intraoperative hemodynamic stability without significant hypotension episodes (MAP > 65 mmHg) or vasopressor requirement beyond baseline anesthesia induction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Adverse Events
A composite endpoint defined as the occurrence of any of the following within 30 days post-surgery: Postoperative Delirium (assessed by CAM-ICU), Acute Kidney Injury (KDIGO criteria stage 1 or higher), Stroke (new neurological deficit confirmed by imaging), or All-cause Mortality.
Measured: Up to 30 days post-operation
Secondary outcomes (3)
Duration of Mechanical Ventilation
Time from ICU admission to successful extubation (in hours).
Measured: Up to 30 days
Length of Hospital Stay
Total duration of hospital stay from surgery to discharge (in days)
Measured: Up to 30 days
Length of Intensive Care Unit (ICU) Stay
Time from admission to the Intensive Care Unit immediately after surgery until discharge to the ward (in days).
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start26 Apr 2025
- Primary completion20 Aug 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies 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
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Uzundere, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324694
- Sponsor's protocol ID
- GYTRH-KVC-IOHI-01
- Status last verified
- Oct 2026
- First submitted
- 23 Dec 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen X, Tao H, Chen W, Sun J, Jin R, Zhang W, Hong L, Zhang C. Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery. BMC Anesthesiol. 2024 Nov 25;24(1):424. doi: 10.1186/s12871-024-02817-x.
PubMed 39581994D'Amico F, Fominskiy EV, Turi S, Pruna A, Fresilli S, Triulzi M, Zangrillo A, Landoni G. Intraoperative hypotension and postoperative outcomes: a meta-analysis of randomised trials. Br J Anaesth. 2023 Nov;131(5):823-831. doi: 10.1016/j.bja.2023.08.026. Epub 2023 Sep 20.
PubMed 37739903Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941.
PubMed 30624247
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Hemodynamic Instability on Postoperative Major Adverse Events in Cardiac Surgery Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07324694
- Acronym / sponsor ID
- GYTRH-KVC-IOHI-01
- Conditions
- Cardiac Surgery, Intraoperative Hemodynamic Instability, Postoperative Complication, Acute Kidney Injury, Postoperative Delirium (POD)
- Keywords
- Intraoperative Hypotension, Cardiopulmonary Bypass, Mean Arterial Pressure, Cohort Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 7 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.
Intraoperative hemodynamic instability (IOHI) is a common occurrence during cardiac surgery and is associated with organ hypoperfusion. However, the specific impact of IOHI on composite adverse outcomes remains unclear. This prospective cohort study aims to evaluate the association between intraoperative hemodynamic instability (defined as MAP < 65 mmHg or vasopressor requirement) and major postoperative complications (Delirium, Acute Kidney Injury, Stroke, or Mortality) in adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.
Detailed description
Hemodynamic instability during cardiac surgery is a critical factor influencing postoperative recovery. While transient hypotension is common, prolonged instability may lead to end-organ damage due to hypoperfusion. This prospective observational study will be conducted at the University of Health Sciences Gazi Yasargil Training and Research Hospital.
Patients scheduled for elective cardiac surgery (Coronary Artery Bypass Grafting, Valve replacement/repair, or combined procedures) utilizing cardiopulmonary bypass will be enrolled. Intraoperative hemodynamic data, including Mean Arterial Pressure (MAP), heart rate, and vasoactive medication requirements, will be recorded.
Patients will be categorized into two groups based on intraoperative stability:
- Hemodynamic Instability Group: Patients experiencing MAP < 65 mmHg for more than 5 minutes continuously or requiring significant vasopressor/inotropic support to maintain target pressure.
- Stable Group: Patients maintaining hemodynamic stability without significant hypotensive episodes.
The primary endpoint is a composite of major adverse events within 30 days, including Postoperative Delirium (assessed via CAM-ICU), Acute Kidney Injury (KDIGO criteria), Stroke, and All-cause Mortality. Secondary endpoints include the duration of mechanical ventilation and length of ICU/hospital stay. The study aims to provide evidence-based thresholds for intraoperative blood pressure management to improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic Instability Group | – | –Patients who exhibit intraoperative hemodynamic instability, defined as Mean Arterial Pressure (MAP) < 65 mmHg for >5 minutes continuously, or requiring vasopressor/inotropic support to maintain MAP. |
| Hemodynamically Stable Group | – | –Patients who maintain intraoperative hemodynamic stability without significant hypotension episodes (MAP > 65 mmHg) or vasopressor requirement beyond baseline anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at a tertiary care university hospital.
Key inclusion criteria (5 listed)
- Patients aged 18 years or older.
- Scheduled for elective cardiac surgery (CABG, Valve replacement/repair, or combined procedures).
- Surgery performed under cardiopulmonary bypass (CPB).
- Preoperative sinus rhythm.
- Signed informed consent form.
Key exclusion criteria (6 listed)
- Emergency or salvage surgery.
- Off-pump coronary artery bypass grafting.
- Preoperative mechanical circulatory support (IABP, ECMO) requirement.
- Pre-existing chronic renal failure requiring dialysis (HD/PD).
- Pre-existing cognitive impairment, dementia, or history of psychiatric disorders affecting cooperation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Composite Adverse Events
Time frame: Up to 30 days post-operation
A composite endpoint defined as the occurrence of any of the following within 30 days post-surgery: Postoperative Delirium (assessed by CAM-ICU), Acute Kidney Injury (KDIGO criteria stage 1 or higher), Stroke (new neurological deficit confirmed by imaging), or All-cause Mortality.
3 secondary outcomes
Duration of Mechanical Ventilation
Time frame: Up to 30 days
Length of Hospital Stay
Time frame: Up to 30 days
Length of Intensive Care Unit (ICU) Stay
Time frame: Up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 39581994Shen X, Tao H, Chen W, Sun J, Jin R, Zhang W, Hong L, Zhang C. Perioperative blood pressure variability as a risk factor for postoperative delirium in the patients receiving cardiac surgery. BMC Anesthesiol. 2024 Nov 25;24(1):424. doi: 10.1186/s12871-024-02817-x.
- Results publication: PubMed 37739903D'Amico F, Fominskiy EV, Turi S, Pruna A, Fresilli S, Triulzi M, Zangrillo A, Landoni G. Intraoperative hypotension and postoperative outcomes: a meta-analysis of randomised trials. Br J Anaesth. 2023 Nov;131(5):823-831. doi: 10.1016/j.bja.2023.08.026. Epub 2023 Sep 20.
- Results publication: PubMed 30624247Buitenwerf E, Boekel MF, van der Velde MI, Voogd MF, Kerstens MN, Wietasch GJKG, Scheeren TWL. The haemodynamic instability score: Development and internal validation of a new rating method of intra-operative haemodynamic instability. Eur J Anaesthesiol. 2019 Apr;36(4):290-296. doi: 10.1097/EJA.0000000000000941.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Intraoperative Hemodynamic Instability, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Composite Adverse Events (time frame: Up to 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07324694, which also lists 3 linked publications.
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 Oct 2026.