Clinical trial · Observational
GDFT and Postoperative Cognitive Function in Geriatric Cancer Surgery
Intraoperative Goal-Directed Fluid Therapy and Postoperative Cognitive Outcomes in Geriatric Patients Undergoing Major Cancer Surgeries: A Comparative Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasm | — | UNRESOLVED | — |
| Geriatrics | — | UNRESOLVED | — |
| Hemodynamics | — | UNRESOLVED | — |
| Postoperative Cognitive Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Masimo Root Hemodynamic Monitoring | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- GDFT Group (Masimo Root Guided)
- description
- Patients in this group will receive intraoperative GDFT. Hemodynamic monitoring will be performed using the Masimo Root device. Fluid administration (crystalloids and/or colloids) will be titrated based on real-time PVI and PI values to maintain optimal stroke volume and tissue perfusion. The goal is to achieve individualized hemodynamic stability throughout the major abdominal cancer surgery.
- interventionNames
- Device: Masimo Root Hemodynamic Monitoring
- label
- Conventional Group (Standard Care)
- description
- Patients in this group will receive conventional fluid therapy based on standard clinical guidelines. Fluid requirements will be calculated using the traditional "4:2:1" rule (physiological requirement + estimated blood loss + third-space fluid loss). Intraoperative fluid management will rely on routine monitoring (heart rate, mean arterial pressure, and urine output) without the use of advanced hemodynamic parameters like PVI or PI from the Masimo Root device
Primary outcomes (1)
- measure
- Change in Postoperative Cognitive Function (MMSE Scores)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (3)
- BACKGROUNDWu B, Guo Y, Min S, Xiong Q, Zou L. Postoperative cognitive dysfunction in elderly patients with colorectal cancer: A randomized controlled study comparing goal-directed and conventional fluid therapy. Open Med (Wars). 2024 Mar 27;19(1):20240930. doi: 10.1515/med-2024-0930. eCollection 2024. PMID 38584828
- BACKGROUNDZhang N, Liang M, Zhang DD, Xiao YR, Li YZ, Gao YG, Cai HD, Lin XZ, Lin CZ, Zeng K, Wu XD. Effect of goal-directed fluid therapy on early cognitive function in elderly patients with spinal stenosis: A Case-Control Study. Int J Surg. 2018 Jun;54(Pt A):201-205. doi: 10.1016/j.ijsu.2018.04.007. Epub 2018 Apr 17. PMID 29678619
- BACKGROUNDZhang J, Qiao H, He Z, Wang Y, Che X, Liang W. Intraoperative fluid management in open gastrointestinal surgery: goal-directed versus restrictive. Clinics (Sao Paulo). 2012 Oct;67(10):1149-55. doi: 10.6061/clinics/2012(10)06. PMID 23070341