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NCT Number: NCT07438249

GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery

Postoperative cognitive decline remains a common and clinically significant complication among geriatric patients undergoing major abdominal cancer surgery. Age-related physiological vulnerability, impaired cerebral autoregulation, and perioperative hemodynamic instability contribute to the development of postoperative neurocognitive impairment.

Goal-directed fluid therapy (GDFT), guided by dynamic hemodynamic parameters, has been proposed as an individualized approach to optimize tissue perfusion while avoiding both hypovolemia and fluid overload. Non-invasive monitoring technologies, such as pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the risks associated with invasive monitoring, making them particularly suitable for elderly surgical populations.

This prospective observational cohort study aims to evaluate the association between intraoperative PVI/PI-guided GDFT and postoperative cognitive outcomes in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to routine clinical practice, either with individualized GDFT or conventional fluid therapy, as determined by the attending anesthesiologist.

The primary outcome is the change in cognitive function, assessed using Mini-Mental State Examination (MMSE) scores from baseline to postoperative day 1 and postoperative day 7. Longitudinal changes in cognitive function will be analyzed using adjusted statistical models to account for repeated measurements over time and potential confounding factors, including age, ASA physical status, duration of surgery, and intraoperative blood loss.

Secondary outcomes include intraoperative fluid administration, hemodynamic parameters, estimated blood loss, and net fluid balance. The study is designed to provide clinically relevant evidence on whether individualized, non-invasive hemodynamic monitoring strategies are associated with improved perioperative physiological stability and early postoperative cognitive recovery in elderly surgical patients.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea

Ankara, Yenimahalle, 06200, Turkey (Türkiye)

About this study

Postoperative neurocognitive disorders, including early postoperative cognitive decline, represent a significant source of morbidity in geriatric patients undergoing major abdominal cancer surgery. These impairments are multifactorial and are thought to arise from the interaction of perioperative hemodynamic instability, impaired cerebral autoregulation, systemic inflammatory responses, and age-related reductions in physiological reserve.

Among perioperative factors, intraoperative fluid management plays a central role in maintaining adequate tissue perfusion and organ function. Both hypovolemia and fluid overload have been associated with adverse outcomes, including impaired microcirculatory perfusion and potential effects on cerebral oxygen delivery. Traditional fluid management strategies, typically based on fixed formulas and static physiological parameters, may not adequately reflect inter-individual variability, particularly in elderly patients with altered cardiovascular compliance and limited adaptive capacity.

Goal-directed fluid therapy (GDFT) has emerged as an individualized hemodynamic management strategy aimed at optimizing stroke volume and tissue perfusion through the use of dynamic indicators of fluid responsiveness. While randomized trials and meta-analyses have demonstrated that GDFT can improve perioperative outcomes such as complication rates and length of hospital stay, its impact on postoperative cognitive outcomes remains insufficiently characterized, especially in oncologic geriatric populations.

Recent advances in non-invasive hemodynamic monitoring technologies, including the use of pleth variability index (PVI) and perfusion index (PI), allow continuous assessment of fluid responsiveness without the need for invasive cardiac output monitoring. These tools offer a practical and safer alternative in routine clinical practice, particularly in elderly patients where invasive monitoring may not always be feasible.

This study is designed as a prospective observational cohort study conducted in geriatric patients undergoing elective major abdominal cancer surgery. Patients are managed according to standard clinical practice, and intraoperative fluid management strategy-either PVI/PI-guided GDFT or conventional fluid therapy-is determined by the attending anesthesiologist. No intervention is assigned by the study protocol, and no modification of routine clinical care is performed.

The primary objective of the study is to evaluate the association between intraoperative fluid management strategy and postoperative cognitive trajectory. Cognitive function is assessed using the Mini-Mental State Examination (MMSE) at three time points: preoperatively (baseline), postoperative day 1, and postoperative day 7. The primary outcome is defined as the change in MMSE scores over time.

To appropriately account for repeated cognitive measurements and potential confounding, longitudinal statistical models will be employed. Specifically, mixed-effects modeling will be used to evaluate the interaction between time and fluid management strategy, while adjusting for clinically relevant covariates, including age, ASA physical status, duration of surgery, and intraoperative blood loss.

Secondary objectives include evaluating the association between fluid management strategy and intraoperative physiological parameters, including total fluid administered, mean arterial pressure, heart rate, estimated blood loss, and net fluid balance.

Given the observational nature of the study, results will be interpreted as associations rather than causal effects. The study aims to generate clinically relevant evidence regarding whether individualized, non-invasive, goal-directed fluid strategies are associated with improved early postoperative cognitive recovery and optimized perioperative physiological stability in geriatric surgical patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 65 years (geriatric patients)
  • Scheduled for elective major abdominal cancer surgery
  • American Society of Anesthesiologists (ASA) Physical Status I-IV
  • Eastern Cooperative Oncology Group (ECOG/WHO/Zubrod) performance status ≥ 2
  • Ability to complete cognitive assessments
  • Provision of written informed consent

Exclusion criteria

  • Severe cardiac dysfunction (Cardiac Index ≤ 2.2 L/min/m²)
  • History of neurological or psychiatric disorders (e.g., dementia, Alzheimer's disease)
  • Use of medications that significantly affect cognitive function
  • Severe hepatic or renal failure
  • Prior chemotherapy or radiotherapy before surgery
  • Intraoperative or perioperative blood transfusion
  • Prolonged mechanical ventilation (inability to extubate immediately after surgery)
  • Pre-existing cognitive impairment (baseline Mini-Mental State Examination [MMSE] score < 24)

Treatment and study plan

Masimo Root Hemodynamic Monitoring

Device

Use of PVI and PI parameters to guide intraoperative fluid titration.

Primary outcomes

  1. Change in Postoperative Cognitive Function (MMSE Scores)

    Time frame: Preoperative (Baseline), Postoperative Day 1, and Postoperative Day 7.

    The primary outcome is the assessment of cognitive function using the Mini-Mental State Examination. The MMSE is a 30-point questionnaire used to measure cognitive impairment. Scores range from 0 to 30, where lower scores indicate greater cognitive impairment (e.g., <24 is typically considered indicative of cognitive dysfunction). The study will compare the incidence of POCD between the GDFT group (monitored via Masimo Root PVI/PI) and the conventional fluid therapy group.

Secondary outcomes

  1. Total Intraoperative Fluid Volume

    Time frame: From induction of anesthesia to the end of surgery (assessed intraoperatively, up to approximately 4 hours)

    Total volume of intravenous fluids administered during surgery, including crystalloids, colloids, and blood products.

  2. Intraoperative Mean Arterial Pressure (MAP)

    Time frame: Baseline (pre-induction), intraoperative 1st hour, intraoperative 2nd hour

    Mean arterial pressure values recorded at predefined intraoperative time points to assess hemodynamic stability

  3. Intraoperative Heart Rate (HR)

    Time frame: Intraoperative period (baseline, 1st hour, 2nd hour)

    Heart rate measurements recorded during surgery as an indicator of cardiovascular response

  4. Estimated Blood Loss

    Time frame: Intraoperative period

    Total estimated intraoperative blood loss recorded by the anesthesia and surgical team

  5. Net Fluid Balance

    Time frame: From induction of anesthesia to the end of surgery (calculated at the end of surgery, over an intraoperative period of up to approximately 4 hours).

    Difference between total fluid input (intravenous fluids) and output (urine output and estimated blood loss).

  6. Change in Mean Arterial Pressure Over Time

    Time frame: Baseline, intraoperative 1st hour, intraoperative 2nd hour

    Longitudinal change in MAP across intraoperative time points to evaluate hemodynamic trends

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Official study title

Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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