Effect of Targeted Fluid Therapy on Postoperative Cognitive Dysfunction.

NCT06797713 | Completed

• 1 other identifier: 2024/282
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Cognitive Dysfunction, Postoperative

Keywords

Goal-directed fluid treapy; Postoperative cognitive dysfunction; Coronary artery bypass graft surgery; conventional fluid therapy

Outcome Measures

Primary Outcomes (1)

• Postoperative cognitive disfunction

  TFT affects postoperative cognitive dysfunction.

  The evaluation will be completed 4 weeks after the intraoperative TFT.

Study Arms (2)

Group (D): Doppler Group

ACTIVE COMPARATOR

Patient group receiving targeted fluid therapy with esophageal doppler

Procedure: Esophageal doppler

Group (C): Control Group

SHAM COMPARATOR

Group of patients receiving conventional fluid therapy

Procedure: Conventional method

Interventions

Esophageal doppler PROCEDURE

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.

Group (D): Doppler Group

Conventional method PROCEDURE

Fluid therapy is performed by monitoring parameters such as blood pressure, urine output, lactate...

Group (C): Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who will undergo coronary artery bypass surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Melikgazi, Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 28, 2025
• Study Start: July 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: January 15, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

TU (1)