Prostate CancerNCT07806539
Hemodynamic Monitoring-Guided Goal-Directed Fluid Therapy in Robotic Radical Prostatectomy
An observational study of Prostate Cancer and Robotic Radical Prostatectomy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Robotic Radical Prostatectomy
- What is being tested?
- LiDCO-guided goal-directed fluid therapy and Conventional fluid therapy
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Feb 2026to 15 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Adult male patients aged 18-80 years with prostate cancer who are scheduled for elective robotic radical prostatectomy at Antalya Training and Research Hospital and meet the study eligibility criteria will be prospectively enrolled after providing written informed consent.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya, 07070
About this study
Official title: Effectiveness of Goal-Directed Fluid Therapy Guided by Minimally Invasive Hemodynamic Monitoring in Robotic Radical Prostatectomy: A Prospective Observational Study
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Robotic Radical Prostatectomy
- Being tested
- LiDCO-guided goal-directed fluid therapy, Conventional fluid therapy
- Keywords
- Minimally invasive hemodynamic monitoring, LiDCO, Stroke volume variation, Perioperative fluid management, Goal-directed fluid therapy, Robotic radical prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiDCO-guided goal-directed fluid therapyOther
Intraoperative fluid management guided by minimally invasive hemodynamic monitoring using LiDCO®Rapid during robotic radical prostatectomy.
Conventional fluid therapyOther
Standard intraoperative fluid management based on routine clinical assessment and conventional hemodynamic parameters during robotic radical prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| LiDCO-guided goal-directed fluid therapy | Patients managed with minimally invasive hemodynamic monitoring-guided goal-directed fluid therapy during robotic radical prostatectomy. Receives: Other: LiDCO-guided goal-directed fluid therapy | |
| Conventional fluid therapy | Patients managed with conventional intraoperative fluid therapy during robotic radical prostatectomy. Receives: Other: Conventional fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative crystalloid fluid volume administered
Total volume of crystalloid fluid administered during the intraoperative period in patients undergoing robotic radical prostatectomy.
Measured: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.
Secondary outcomes (5)
Perioperative changes in arterial blood lactate levels
Arterial blood lactate levels measured at baseline, at 2-hour intervals during surgery, and at 8 hours after the end of surgery.
Measured: From baseline measurement at the beginning of surgery to 8 hours after the end of surgery.
Incidence of intraoperative vasopressor use
Number of participants requiring any vasopressor administration during the intraoperative period.
Measured: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.
Postoperative blood urea nitrogen (BUN) change
Change in blood urea nitrogen (BUN) level from the preoperative baseline value to the postoperative 8th-hour value.
Measured: From preoperative baseline measurement to 8 hours after the end of surgery.
Postoperative serum creatinine change
Change in serum creatinine level from the preoperative baseline value to the postoperative 8th-hour value.
Measured: From preoperative baseline measurement to 8 hours after the end of surgery.
Postoperative estimated glomerular filtration rate (eGFR) change
Change in estimated glomerular filtration rate (eGFR) from the preoperative baseline value to the postoperative 8th-hour value.
Measured: From preoperative baseline measurement to 8 hours after the end of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start23 Feb 2026
- Primary completion3 Jul 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806539
- Sponsor's protocol ID
- AEAH-RARP-HYST-2026-001
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy considerations.
Publications
Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
PubMed 21705869Jun JH, Chung RK, Baik HJ, Chung MH, Hyeon JS, Lee YG, Park SH. The tidal volume challenge improves the reliability of dynamic preload indices during robot-assisted laparoscopic surgery in the Trendelenburg position with lung-protective ventilation. BMC Anesthesiol. 2019 Aug 7;19(1):142. doi: 10.1186/s12871-019-0807-6.
PubMed 31390982Ostermann M, Auzinger G, Grocott M, Morton-Bailey V, Raphael J, Shaw AD, Zarbock A; POQI XI Investigators. Perioperative fluid management: evidence-based consensus recommendations from the international multidisciplinary PeriOperative Quality Initiative. Br J Anaesth. 2024 Dec;133(6):1263-1275. doi: 10.1016/j.bja.2024.07.038. Epub 2024 Sep 27.
PubMed 39341776Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
PubMed 29742967
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Goal-Directed Fluid Therapy Guided by Minimally Invasive Hemodynamic Monitoring in Robotic Radical Prostatectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07806539
- Acronym / sponsor ID
- AEAH-RARP-HYST-2026-001
- Conditions
- Prostate Cancer, Robotic Radical Prostatectomy
- Keywords
- Minimally invasive hemodynamic monitoring, LiDCO, Stroke volume variation, Perioperative fluid management, Goal-directed fluid therapy, Robotic radical prostatectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 3 Jul 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LiDCO-guided goal-directed fluid therapy | – | Other: LiDCO-guided goal-directed fluid therapyPatients managed with minimally invasive hemodynamic monitoring-guided goal-directed fluid therapy during robotic radical prostatectomy. |
| Conventional fluid therapy | – | Other: Conventional fluid therapyPatients managed with conventional intraoperative fluid therapy during robotic radical prostatectomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male patients aged 18-80 years with prostate cancer who are scheduled for elective robotic radical prostatectomy at Antalya Training and Research Hospital and meet the study eligibility criteria will be prospectively enrolled after providing written informed consent.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiDCO-guided goal-directed fluid therapyIntraoperative fluid management guided by minimally invasive hemodynamic monitoring using LiDCO®Rapid during robotic radical prostatectomy. | Other | LiDCO-guided goal-directed fluid therapy |
| Conventional fluid therapyStandard intraoperative fluid management based on routine clinical assessment and conventional hemodynamic parameters during robotic radical prostatectomy. | Other | Conventional fluid therapy |
Primary outcome
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.
5 secondary outcomes
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.
Incidence of intraoperative vasopressor use
Time frame: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.
Postoperative blood urea nitrogen (BUN) change
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Postoperative serum creatinine change
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Postoperative estimated glomerular filtration rate (eGFR) change
Time frame: From preoperative baseline measurement to 8 hours after the end of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 21705869Cannesson M, Le Manach Y, Hofer CK, Goarin JP, Lehot JJ, Vallet B, Tavernier B. Assessing the diagnostic accuracy of pulse pressure variations for the prediction of fluid responsiveness: a "gray zone" approach. Anesthesiology. 2011 Aug;115(2):231-41. doi: 10.1097/ALN.0b013e318225b80a.
- Background: PubMed 31390982Jun JH, Chung RK, Baik HJ, Chung MH, Hyeon JS, Lee YG, Park SH. The tidal volume challenge improves the reliability of dynamic preload indices during robot-assisted laparoscopic surgery in the Trendelenburg position with lung-protective ventilation. BMC Anesthesiol. 2019 Aug 7;19(1):142. doi: 10.1186/s12871-019-0807-6.
- Background: PubMed 39341776Ostermann M, Auzinger G, Grocott M, Morton-Bailey V, Raphael J, Shaw AD, Zarbock A; POQI XI Investigators. Perioperative fluid management: evidence-based consensus recommendations from the international multidisciplinary PeriOperative Quality Initiative. Br J Anaesth. 2024 Dec;133(6):1263-1275. doi: 10.1016/j.bja.2024.07.038. Epub 2024 Sep 27.
- Background: PubMed 29742967Myles PS, Bellomo R, Corcoran T, Forbes A, Peyton P, Story D, Christophi C, Leslie K, McGuinness S, Parke R, Serpell J, Chan MTV, Painter T, McCluskey S, Minto G, Wallace S; Australian and New Zealand College of Anaesthetists Clinical Trials Network and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Restrictive versus Liberal Fluid Therapy for Major Abdominal Surgery. N Engl J Med. 2018 Jun 14;378(24):2263-2274. doi: 10.1056/NEJMoa1801601. Epub 2018 May 9.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Robotic Radical Prostatectomy, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative crystalloid fluid volume administered (time frame: From anesthesia induction to the end of surgery, assessed over approximately 5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07806539, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.