Cognitive Dysfunction, PostoperativeNCT06797713
Effect of Targeted Fluid Therapy on Postoperative Cognitive Dysfunction.
A study testing Esophageal doppler and Conventional method in people with Cognitive Dysfunction, Postoperative, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
Postoperative cognitive dysfunction (POCD) describes a decline in cognitive function as measured by pre- and postoperative neuropsychological testing. It is common after cardiac surgery, affecting 25% to 70% of patients, and is usually associated with pathophysiological mechanisms such as cerebral hypoperfusion… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cognitive Dysfunction, Postoperative
- What is being tested?
- Esophageal doppler and Conventional method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 Jan 2026
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo coronary artery bypass surgery.
Who cannot join
- Patients with mental disorders or neurological diseases.
- Illiterate people
- Patients who use medication that affects cognitive function
- Emergency surgeries
- Patients with end-stage renal failure
- Patients who are receiving antidepressant and antipsychotic treatment
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Perioperative Targeted Fluid Therapy on Postoperative Cognitive Dysfunction in Coronary Artery Bypass Surgery.
Postoperative cognitive dysfunction (POCD) describes a decline in cognitive function as measured by pre- and postoperative neuropsychological testing. It is common after cardiac surgery, affecting 25% to 70% of patients, and is usually associated with pathophysiological mechanisms such as cerebral hypoperfusion, cerebral microemboli, glycaemic control and neurotoxic effects of anaesthetic agents. There are similar mechanisms between POCD and postoperative delirium (POD), both of which promote neuroinflammation through systemic inflammation and blood-brain barrier dysfunction. It has also been associated with concentrations of peripheral inflammatory markers (such as CRP, IL-6). The aim of this study was to examine the pathophysiological processes leading to cognitive dysfunction after cardiac surgery and to evaluate the role of targeted fluid therapy in these conditions. Targeted fluid therapy aims to optimise fluid, inotrope and vasopressor therapy by monitoring haemodynamic parameters (stroke volume, cardiac output, systemic vascular resistance, etc.).
This treatment may improve tissue perfusion, reduce the inflammatory response and reduce mortality. In this study, the optimisation of fluid therapy during cardiac surgery was achieved by using monitors based on oesophageal doppler and pulse contour analysis. The effectiveness of these methods in reducing major complications and improving clinical outcomes will be evaluated.
Read the detailed description
Postoperative cognitive dysfunction (POCD) is cognitive dysfunction defined as a decline in cognitive function from baseline performance as measured by neuropsychological tests before and after surgery. Perioperative neurocognitive impairment includes preoperative neurocognitive impairment, POCD and postoperative delirium (POD). It is extremely common after cardiac surgery and affects 25% to 70% of patients. The underlying pathophysiological mechanisms leading to cognitive impairment are unclear, but many factors have been implicated in the aetiology. Pathophysiological mechanisms leading to cognitive dysfunction following cardiac surgery such as cerebral hypoperfusion, cerebral microemboli, glycaemic control and possible neurotoxic effects of anaesthetic agents have been demonstrated in the literature. The increase in the frequency of neurocognitive impairments leads to prolonged hospitalisation and increased healthcare costs. Although there are many clinical differences between POD and POCD, both lead to blood-brain barrier dysfunction and promote neuroinflammation through a systemic inflammatory response triggered by surgical trauma.
It has been shown that NOD-LRR- and pyrin domain-containing protein 3 (NLRP3) increased in the hippocampus of mice after cardiac surgery, causing hippocampal inflammation and cognitive dysfunction. In another study, it was reported that microglia in the hippocampus of rats were activated, the amount of inflammatory factors such as IL-1β, IL-6 and TNF-α increased and the permeability of the blood-brain barrier increased. POD and POCD were also found to be closely related with the concentration of peripheral inflammatory markers (such as CRP, IL-6).
Targeted fluid therapy (TFT) in cardiac surgery is the use of various haemodynamic parameters (e.g. stroke volume, cardiac output, systemic vascular resistance and stroke volume variation) and optimisation of fluids, inotropes and vasopressors to ensure adequate tissue perfusion. Because administration of more or less fluid and blood products than needed will cause many undesirable clinical conditions in patients (in case of over administration; pulmonary oedema, tissue oedema, connective and mucosal oedema or in case of under administration; perfusion failure in peripheral tissue and brain, hypotension). The aim of targeted fluid therapy is to use haemodynamic parameters that allow us to monitor the amount of fluid, inotrope requirement, tissue blood flow and oxygenation. This optimization reduces mortality by providing normal tissue perfusion, preventing inflammatory response and possible fatal complications. There are many monitors on the market that have developed rapidly in recent years and are now used in many anaesthesia clinics for perioperative volume management. When choosing this, the aim should be to select the technology that provides the most accurate and relevant haemodynamic data, taking into account the safety, comfort and general care of the patient.
For targeted fluid therapy, techniques/monitors routinely used in clinics that have them include PiCCO plus, FloTrac/EV1000, oesophageal doppler and pulmonary artery catheter. In a study conducted in major abdominal surgeries, patients followed up with Vigileo/FloTrac, which uses the principle of oesophageal doppler and pulse contour analysis for targeted fluid therapy, were compared and it was shown that major complications and mortality decreased and it was reported that the monitors were cost effective . The fact that the sternum is open in cardiac surgery is an important limitation of monitors working on the principle of pulse contour analysis. Therefore, in this study, we planned to perform advanced haemodynamic monitoring with oesophageal Doppler and to decide on fluid/blood/inotrope support by using many parameters such as stroke volume, cardiac index, oxygen delivery, and stroke volume variation (SVV) on this monitor.
- Conditions
- Cognitive Dysfunction, Postoperative
- Being tested
- Esophageal doppler, Conventional method
- Keywords
- Goal-directed fluid treapy, Postoperative cognitive dysfunction, Coronary artery bypass graft surgery, conventional fluid therapy
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophageal dopplerProcedure or surgery
Fluid/inotrope decisions will be made with parameters such as stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PVV), systemic vascular resistance (SVR), and cardiac output (CO) on the Doppler monitor screen.
Conventional methodProcedure or surgery
Fluid therapy is performed by monitoring parameters such as blood pressure, urine output, lactate...
| Study group | Role | What they receive |
|---|---|---|
| Group (D): Doppler Group | Active comparator | Patient group receiving targeted fluid therapy with esophageal doppler Receives: Procedure: Esophageal doppler |
| Group (C): Control Group | Sham comparator | Group of patients receiving conventional fluid therapy Receives: Procedure: Conventional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cognitive disfunction
TFT affects postoperative cognitive dysfunction.
Measured: The evaluation will be completed 4 weeks after the intraoperative TFT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Jul 2025
- Primary completion15 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Dysfunction, PostoperativeStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will have a Montreal cognitive assessment questionnaire (MOKA) for cognitive dysfunction one day before the operation and blood will be taken to the biochemistry tube to study NLRP3, IL-18, IL-1 beta and caspase 1 simultaneously. In the group where targeted fluid therapy will be applied (Group D,n=30), esophageal doppler will be placed, fluid, inotropes, blood replacements will be made according to the recommendations of the guidelines on this subject (such as stroke volume, SVV, oxygen delivery, etc.). Patients in the control group (Group C, n=30) will receive fluid and blood product treatment by following standard parameters (blood pressure, urine output, serum lactate level, base excess). Delirium will be monitored with the confusion assessment method every day for 7 days postoperatively. The MOKA test will be repeated on the 7th and 30th days postoperatively,blood samples will be taken and NLRP-3, IL-1 beta, IL-18, caspase-1 will be studied.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Talih, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797713
- Sponsor's protocol ID
- 2024/282
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Targeted Fluid Therapy on Postoperative Cognitive Dysfunction in Coronary Artery Bypass Surgery.
- ClinicalTrials.gov ID
- NCT06797713
- Acronym / sponsor ID
- 2024/282
- Conditions
- Cognitive Dysfunction, Postoperative
- Keywords
- Goal-directed fluid treapy, Postoperative cognitive dysfunction, Coronary artery bypass graft surgery, conventional fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 28 Jan 2025 (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.
Postoperative cognitive dysfunction (POCD) describes a decline in cognitive function as measured by pre- and postoperative neuropsychological testing. It is common after cardiac surgery, affecting 25% to 70% of patients, and is usually associated with pathophysiological mechanisms such as cerebral hypoperfusion, cerebral microemboli, glycaemic control and neurotoxic effects of anaesthetic agents. There are similar mechanisms between POCD and postoperative delirium (POD), both of which promote neuroinflammation through systemic inflammation and blood-brain barrier dysfunction. It has also been associated with concentrations of peripheral inflammatory markers (such as CRP, IL-6). The aim of this study was to examine the pathophysiological processes leading to cognitive dysfunction after cardiac surgery and to evaluate the role of targeted fluid therapy in these conditions. Targeted fluid therapy aims to optimise fluid, inotrope and vasopressor therapy by monitoring haemodynamic parameters (stroke volume, cardiac output, systemic vascular resistance, etc.).
This treatment may improve tissue perfusion, reduce the inflammatory response and reduce mortality. In this study, the optimisation of fluid therapy during cardiac surgery was achieved by using monitors based on oesophageal doppler and pulse contour analysis. The effectiveness of these methods in reducing major complications and improving clinical outcomes will be evaluated.
Detailed description
Postoperative cognitive dysfunction (POCD) is cognitive dysfunction defined as a decline in cognitive function from baseline performance as measured by neuropsychological tests before and after surgery. Perioperative neurocognitive impairment includes preoperative neurocognitive impairment, POCD and postoperative delirium (POD). It is extremely common after cardiac surgery and affects 25% to 70% of patients. The underlying pathophysiological mechanisms leading to cognitive impairment are unclear, but many factors have been implicated in the aetiology. Pathophysiological mechanisms leading to cognitive dysfunction following cardiac surgery such as cerebral hypoperfusion, cerebral microemboli, glycaemic control and possible neurotoxic effects of anaesthetic agents have been demonstrated in the literature. The increase in the frequency of neurocognitive impairments leads to prolonged hospitalisation and increased healthcare costs. Although there are many clinical differences between POD and POCD, both lead to blood-brain barrier dysfunction and promote neuroinflammation through a systemic inflammatory response triggered by surgical trauma.
It has been shown that NOD-LRR- and pyrin domain-containing protein 3 (NLRP3) increased in the hippocampus of mice after cardiac surgery, causing hippocampal inflammation and cognitive dysfunction. In another study, it was reported that microglia in the hippocampus of rats were activated, the amount of inflammatory factors such as IL-1β, IL-6 and TNF-α increased and the permeability of the blood-brain barrier increased. POD and POCD were also found to be closely related with the concentration of peripheral inflammatory markers (such as CRP, IL-6).
Targeted fluid therapy (TFT) in cardiac surgery is the use of various haemodynamic parameters (e.g. stroke volume, cardiac output, systemic vascular resistance and stroke volume variation) and optimisation of fluids, inotropes and vasopressors to ensure adequate tissue perfusion. Because administration of more or less fluid and blood products than needed will cause many undesirable clinical conditions in patients (in case of over administration; pulmonary oedema, tissue oedema, connective and mucosal oedema or in case of under administration; perfusion failure in peripheral tissue and brain, hypotension). The aim of targeted fluid therapy is to use haemodynamic parameters that allow us to monitor the amount of fluid, inotrope requirement, tissue blood flow and oxygenation. This optimization reduces mortality by providing normal tissue perfusion, preventing inflammatory response and possible fatal complications. There are many monitors on the market that have developed rapidly in recent years and are now used in many anaesthesia clinics for perioperative volume management. When choosing this, the aim should be to select the technology that provides the most accurate and relevant haemodynamic data, taking into account the safety, comfort and general care of the patient.
For targeted fluid therapy, techniques/monitors routinely used in clinics that have them include PiCCO plus, FloTrac/EV1000, oesophageal doppler and pulmonary artery catheter. In a study conducted in major abdominal surgeries, patients followed up with Vigileo/FloTrac, which uses the principle of oesophageal doppler and pulse contour analysis for targeted fluid therapy, were compared and it was shown that major complications and mortality decreased and it was reported that the monitors were cost effective . The fact that the sternum is open in cardiac surgery is an important limitation of monitors working on the principle of pulse contour analysis. Therefore, in this study, we planned to perform advanced haemodynamic monitoring with oesophageal Doppler and to decide on fluid/blood/inotrope support by using many parameters such as stroke volume, cardiac index, oxygen delivery, and stroke volume variation (SVV) on this monitor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will have a Montreal cognitive assessment questionnaire (MOKA) for cognitive dysfunction one day before the operation and blood will be taken to the biochemistry tube to study NLRP3, IL-18, IL-1 beta and caspase 1 simultaneously. In the group where targeted fluid therapy will be applied (Group D,n=30), esophageal doppler will be placed, fluid, inotropes, blood replacements will be made according to the recommendations of the guidelines on this subject (such as stroke volume, SVV, oxygen delivery, etc.). Patients in the control group (Group C, n=30) will receive fluid and blood product treatment by following standard parameters (blood pressure, urine output, serum lactate level, base excess). Delirium will be monitored with the confusion assessment method every day for 7 days postoperatively. The MOKA test will be repeated on the 7th and 30th days postoperatively,blood samples will be taken and NLRP-3, IL-1 beta, IL-18, caspase-1 will be studied.
| Arm | Type | Receives |
|---|---|---|
| Group (D): Doppler Group | Active comparator | Procedure: Esophageal dopplerPatient group receiving targeted fluid therapy with esophageal doppler |
| Group (C): Control Group | Sham comparator | Procedure: Conventional methodGroup of patients receiving conventional fluid therapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who will undergo coronary artery bypass surgery.
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| Esophageal dopplerFluid/inotrope decisions will be made with parameters such as stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PVV), systemic vascular resistance (SVR), and cardiac output (CO) on the Doppler monitor screen. | Procedure or surgery | Group (D): Doppler Group |
| Conventional methodFluid therapy is performed by monitoring parameters such as blood pressure, urine output, lactate... | Procedure or surgery | Group (C): Control Group |
Primary outcome
Postoperative cognitive disfunction
Time frame: The evaluation will be completed 4 weeks after the intraoperative TFT.
TFT affects postoperative cognitive dysfunction.
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 3 Mar 2026.
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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?
A study testing Esophageal doppler and Conventional method in people with Cognitive Dysfunction, Postoperative, run by TC Erciyes University 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 1 inclusion and 7 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 3 Mar 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. Some participants in this study may receive a placebo. 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?
Postoperative cognitive disfunction (time frame: The evaluation will be completed 4 weeks after the intraoperative TFT.). 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 3 Mar 2026.