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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Erciyes University

    Melikgazi, Kayseri

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06797713
Study groupRoleWhat they receive
Group (D): Doppler GroupActive comparatorPatient group receiving targeted fluid therapy with esophageal doppler
Receives: Procedure: Esophageal doppler
Group (C): Control GroupSham comparatorGroup 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.

  1. 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.

  1. First posted28 Jan 2025
  2. Study start1 Jul 2025
  3. Primary completion15 Nov 2025
  4. Study completion15 Jan 2026

Resources

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)
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

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.

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