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NCT Number: NCT07806539

Hemodynamic Monitoring-Guided Goal-Directed Fluid Therapy in Robotic Radical Prostatectomy

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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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Antalya Training and Research Hospital

Antalya, 07070, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male patients aged 18 to 80 years
  • Patients scheduled for elective robotic radical prostatectomy
  • American Society of Anesthesiologists physical status I-III
  • Patients who provide written informed consent

Exclusion criteria

  • Refusal to participate in the study
  • Cardiac rhythm disturbances
  • Severe left ventricular dysfunction, defined as ejection fraction <40%
  • Severe valvular heart disease or active heart failure
  • Chronic renal failure, dialysis dependency, or preoperative creatinine >2 mg/dL
  • Hemoglobin <8 g/dL
  • Pre-existing hematological conditions requiring planned blood transfusion
  • Body mass index >40 kg/m²
  • Major peripheral vascular disease
  • Implanted pacemaker or implantable cardioverter-defibrillator
  • Chronic obstructive pulmonary disease
  • Conditions associated with increased intra-abdominal pressure
  • Emergency surgery

Treatment and study plan

LiDCO-guided goal-directed fluid therapy

Other

Intraoperative fluid management guided by minimally invasive hemodynamic monitoring using LiDCO®Rapid during robotic radical prostatectomy.

Conventional fluid therapy

Other

Standard intraoperative fluid management based on routine clinical assessment and conventional hemodynamic parameters during robotic radical prostatectomy.

Primary outcomes

  1. Total intraoperative crystalloid fluid volume administered

    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.

Secondary outcomes

  1. Perioperative changes in arterial blood lactate levels

    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.

  2. Incidence of intraoperative vasopressor use

    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.

  3. Postoperative blood urea nitrogen (BUN) change

    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.

  4. Postoperative serum creatinine change

    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.

  5. Postoperative estimated glomerular filtration rate (eGFR) change

    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.

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Effectiveness of Goal-Directed Fluid Therapy Guided by Minimally Invasive Hemodynamic Monitoring in Robotic Radical Prostatectomy: A Prospective Observational Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 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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