Antalya Training and Research Hospital
Antalya, 07070, Turkey (Türkiye)
NCT Number: NCT07806539
This prospective observational cohort study evaluated goal-directed fluid therapy guided by minimally invasive hemodynamic monitoring in adult male patients undergoing elective robotic radical prostatectomy. Patients were prospectively enrolled and followed according to the intraoperative fluid management strategy used in routine clinical practice.
Patients managed with LiDCO®Rapid-guided goal-directed fluid therapy constituted the hemodynamic monitoring-guided group, while patients managed with conventional intraoperative fluid therapy constituted the control group. No randomization or additional research-related intervention was performed.
The study compared the two fluid management strategies with respect to intraoperative crystalloid fluid administration and selected perioperative clinical and laboratory parameters.
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Notify Me18 year–80 year
Male
Observational
Antalya, 07070, Turkey (Türkiye)
This prospective observational cohort study was conducted in adult male patients undergoing elective robotic radical prostatectomy. The study compared two intraoperative fluid management strategies used in routine clinical practice: conventional fluid therapy and goal-directed fluid therapy guided by minimally invasive hemodynamic monitoring.
In the goal-directed fluid therapy group, intraoperative fluid management was guided by the LiDCO®Rapid hemodynamic monitoring system. A baseline crystalloid infusion of 2 mL/kg/hour was administered. Additional fluid boluses were given according to hemodynamic assessment, particularly when stroke volume variation (SVV) exceeded 15%. Hemodynamic parameters monitored included stroke volume variation, stroke volume, pulse pressure variation, systemic vascular resistance, and cardiac index.
In the conventional fluid therapy group, patients received crystalloid fluid at approximately 4 mL/kg/hour. Additional fluid administration was determined by the attending anesthesiologist according to routine clinical assessment and standard intraoperative monitoring.
All patients underwent standard anesthetic management and routine invasive arterial blood pressure monitoring. Assignment to the fluid management strategy was not randomized and reflected the clinical management approach used during surgery. No additional therapeutic intervention was performed solely for research purposes. Perioperative clinical, hemodynamic, laboratory, and fluid balance data were prospectively recorded for comparison between the two groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative fluid management guided by minimally invasive hemodynamic monitoring using LiDCO®Rapid during robotic radical prostatectomy.
Standard intraoperative fluid management based on routine clinical assessment and conventional hemodynamic parameters during robotic radical prostatectomy.
Time frame: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.
Total volume of crystalloid fluid administered during the intraoperative period in patients undergoing robotic radical prostatectomy.
Time frame: From baseline measurement at the beginning of surgery to 8 hours after the end of surgery.
Arterial blood lactate levels measured at baseline, at 2-hour intervals during surgery, and at 8 hours after the end of surgery.
Time frame: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.
Number of participants requiring any vasopressor administration during the intraoperative period.
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Change in blood urea nitrogen (BUN) level from the preoperative baseline value to the postoperative 8th-hour value.
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Change in serum creatinine level from the preoperative baseline value to the postoperative 8th-hour value.
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Change in estimated glomerular filtration rate (eGFR) from the preoperative baseline value to the postoperative 8th-hour value.
Antalya Training and Research Hospital
Other Gov
Effectiveness of Goal-Directed Fluid Therapy Guided by Minimally Invasive Hemodynamic Monitoring in Robotic Radical Prostatectomy: A Prospective Observational Study
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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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