Acute Kidney InjuryNCT06000098
Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
An observational study of Acute Kidney Injury and Hemodynamic Instability, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Acute Kidney Injury, Hemodynamic Instability
- What is being tested?
- Restrictive fluid therapy
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2023to 16 Oct 2023
- 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 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with restrictive fluid therapy during console period
Who may be able to join
- Patients with American Society Of Anesthesiology physical status 1-3
- Underwent Robotic-assisted laparoscopic prostatectomy
- Underwent restrictive fluid therapy during the console period
Who cannot join
- Under 18 years of age
- Arrhythmia (atrial fibrillation, frequent premature beat)
- History of myocardial infarction in the last 3 months
- Heart failure
- Severe pre-existing lung disease
- Severe valvular heart disease
- Chronic renal disease on dialysis,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy
Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. However, the possible side effects of the deep Trendelenburg's position and the fluid restriction on the cardiovascular and renal systems during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Long console time may contribute to the development of acute kidney injury (AKI) by prolonging the Trendelenburg time and the fluid-restricted time. In this study, investigators aimed to demonstrate the effect of console time on the development of AKI. Investigators also aimed to determine the hemodynamic risk factors that cause the development of AKI in patients monitored with the pressure Recording Analytical Method (PRAM).
Read the detailed description
Although open surgery has been used for a long time in the treatment of prostate diseases, robotic-assisted laparoscopic prostatectomy (RALP) has become more common in the last 20 years. The excellence in results has made the use of the robot the gold standard in prostate surgery. However, the presence of two critical factors during RALP surgery still bothers clinicians. The first of these is severe fluid restriction and the other is the deep Trendelenburg position and pneumoperitoneum. The prolongation of the robotic console time also causes the prolongation of fluid restriction and Trendelenburg time. This combination may cause significant pathophysiological changes in both the renal and cardiac systems and may lead to postoperative acute renal injury (AKI). AKI is a serious clinical complication with increasing incidence and is associated with adverse short-term and long-term outcomes worldwide, resulting in a large healthcare burden. Intraoperative advanced monitoring techniques can contribute to the prevention of renal damage that may occur by providing early recognition of these pathophysiological changes occurring in the renal and cardiac systems.
The aim of our study was to determine the effect of console duration on the incidence of AKI after RALP which was managed using intraoperative advanced monitoring techniques (pressure recording analytical method-PRAM). In addition, this study aimed to evaluate the ability of changes in hemodynamic parameters to predict the development of AKI in RALP patients who underwent restrictive fluid therapy.
- Conditions
- Acute Kidney Injury, Hemodynamic Instability
- Being tested
- Restrictive fluid therapy
- Keywords
- Robotic-assisted laparoscopic prostatectomy, Acute kidney injury, Restrictive fluid therapy, Pressure recording analytical method
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive fluid therapyOther
Also called Trendelenburg position.
0,5 ml/hour fluid administration during prostatic anastomosis.
After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. | Patients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position with restrictive fluid therapy Receives: Other: Restrictive fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury.
Console time ( minute) indicates the restrictive fluid therapy time, prostatic resection, and prostatic urethra anastomosis time.
Measured: The duration of the measurement was defined as during the surgery.
Secondary outcomes (11)
Stroke volume variation (SVV) was measured for evaluation of volume status
Stroke volume variation (SVV,%), was monitored using the pressure recording analytic method. SVV is a parameter used to asses cardiac preload and fluid responsiveness.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Pulse pressure variation (PPV) was measured for evaluation of volume status
Pulse pressure variation (PPV,%) was monitored using the pressure recording analytic method. PPV is a parameter used to asses cardiac preload and fluid responsiveness
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac power output (CPO) was measured for evaluation of cardiac power reserve
Cardiac power output (CPO, Watt) was monitored using the pressure recording analytic method. CPO is a parameter used to asses cardiac reserve
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac index (CI) was measured for evaluating cardiac flow
Cardiac index (CI, L/min/m2), was monitored using the pressure recording analytic method. CI is a parameter used to asses cardiac stroke volume.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Dp/Dt was measured to assess cardiac systolic function
Dp/Dt(mmHg/msn), was monitored using the pressure recording analytic method. Dp/Dt is a parameter used to asses cardiac contractility.
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure
Systolic arterial pressure (SAP- mm/Hg) was monitored using the pressure recording analytic method. SAP is a parameter used to assess the pressure of the arterial system during cardiac systole
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure
Diastolic arterial pressure (DAP, mm/Hg) was monitored using the pressure recording analytic method. DAP is a parameter used to assess the pressure of the arterial system during cardiac diastole
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Mean arterial pressure (MAP) was measured for evaluating perfusion pressure
Mean arterial pressure (MAP, mm/Hg) was monitored using the pressure recording analytic method. MAP is a parameter used to assess organ perfusion
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Heart rate (HR) was measured for evaluating heart ritm
Heart rate( HR, bpm) was monitored using the pressure recording analytic method. HR is a parameter used to assess the cardiac rate
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
Arterial elastance ( Ea) was measured for evaluation of cardiac afterload and arterial ton
Ea ((mmHg m-2ml-1) was monitored using the pressure recording analytic method. Ea is a parameter used to assess cardiac afterload and arterial tone
Measured: The duration of the measurement was defined from one minute before induction to the end of the surgery
The Kidney Disease: Improving Global Outcomes (KDIGO) criteria were used for the definition and staging of acute kidney injury .
KDIGO criteria ( stage) classify acute kidney injury based on changes in serum creatinine levels and urine output.
Measured: The duration of the measurement was defined from the end of the surgery to the 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start25 Sep 2023
- Primary completion15 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fevzi Toraman, M.D., Study director, Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000098
- Sponsor's protocol ID
- ATADEK 2021-01/2
- Status last verified
- Feb 2024
- First submitted
- 11 Aug 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.
PubMed 26844486Sudfeld S, Leyh-Bannurah SR, Budaus L, Graefen M, Reese PC, von Breunig F, Reuter DA, Saugel B. Impact of perioperative administration of 6 % hydroxyethyl starch 130/0.4 on serum cystatin C-derived renal function after radical prostatectomy: a single-centre retrospective study. BMC Anesthesiol. 2016 Aug 30;16(1):69. doi: 10.1186/s12871-016-0236-8.
PubMed 27576693Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
PubMed 21233502Emir NS, Akyol D, Sabaz MS, Karadag S. Robotic assited perineal prostatectomy (RAPP) as a new era for anesthesiology: It's effects on hemodynamic parameters and respiratory mechanics. J Robot Surg. 2023 Jun;17(3):933-940. doi: 10.1007/s11701-022-01482-x. Epub 2022 Nov 16.
PubMed 36383279Valdivieso RF, Hueber PA, Zorn KC. Robot assisted radical prostatectomy: how I do it. Part I: Patient preparation and positioning. Can J Urol. 2013 Oct;20(5):6957-61.
PubMed 24128839Karaveli A, Kavakli AS, Cakin O, Aykal G, Yildiz A, Ates M. Comparison of plasma neutrophil gelatinase-associated lipocalin (NGAL) levels after robot-assisted laparoscopic and retropubic radical prostatectomy: an observational study. Braz J Anesthesiol. 2022 Jan-Feb;72(1):21-28. doi: 10.1016/j.bjane.2021.03.003. Epub 2021 Apr 2.
PubMed 33819496Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.
PubMed 33020097
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT06000098
- Acronym / sponsor ID
- ATADEK 2021-01/2
- Conditions
- Acute Kidney Injury, Hemodynamic Instability
- Keywords
- Robotic-assisted laparoscopic prostatectomy, Acute kidney injury, Restrictive fluid therapy, Pressure recording analytical method
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 21 Aug 2023 (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.
Robotic-assisted laparoscopic prostatectomy (RALP) is the gold standard surgical technique in prostate surgery. Many Robotic-laparoscopic surgical techniques also require the intraoperative deep Trendelenburg position and intravenous fluid restriction during surgery. However, the possible side effects of the deep Trendelenburg's position and the fluid restriction on the cardiovascular and renal systems during surgery are unknown. Although the Trendelenburg position is a life-saving maneuver in hypovolemic patients, it also carries undesirable risks. Long console time may contribute to the development of acute kidney injury (AKI) by prolonging the Trendelenburg time and the fluid-restricted time. In this study, investigators aimed to demonstrate the effect of console time on the development of AKI. Investigators also aimed to determine the hemodynamic risk factors that cause the development of AKI in patients monitored with the pressure Recording Analytical Method (PRAM).
Detailed description
Although open surgery has been used for a long time in the treatment of prostate diseases, robotic-assisted laparoscopic prostatectomy (RALP) has become more common in the last 20 years. The excellence in results has made the use of the robot the gold standard in prostate surgery. However, the presence of two critical factors during RALP surgery still bothers clinicians. The first of these is severe fluid restriction and the other is the deep Trendelenburg position and pneumoperitoneum. The prolongation of the robotic console time also causes the prolongation of fluid restriction and Trendelenburg time. This combination may cause significant pathophysiological changes in both the renal and cardiac systems and may lead to postoperative acute renal injury (AKI). AKI is a serious clinical complication with increasing incidence and is associated with adverse short-term and long-term outcomes worldwide, resulting in a large healthcare burden. Intraoperative advanced monitoring techniques can contribute to the prevention of renal damage that may occur by providing early recognition of these pathophysiological changes occurring in the renal and cardiac systems.
The aim of our study was to determine the effect of console duration on the incidence of AKI after RALP which was managed using intraoperative advanced monitoring techniques (pressure recording analytical method-PRAM). In addition, this study aimed to evaluate the ability of changes in hemodynamic parameters to predict the development of AKI in RALP patients who underwent restrictive fluid therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. | – | Other: Restrictive fluid therapyPatients with ASA( American Society of Anesthesiologists) physical status 1-3 who underwent robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position with restrictive fluid therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with restrictive fluid therapy during console period
Key inclusion criteria (3 listed)
- Patients with American Society Of Anesthesiology physical status 1-3
- Underwent Robotic-assisted laparoscopic prostatectomy
- Underwent restrictive fluid therapy during the console period
Key exclusion criteria (7 listed)
- Under 18 years of age
- Arrhythmia (atrial fibrillation, frequent premature beat)
- History of myocardial infarction in the last 3 months
- Heart failure
- Severe pre-existing lung disease
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 |
|---|---|---|
| Restrictive fluid therapyAlso: Trendelenburg position.0,5 ml/hour fluid administration during prostatic anastomosis. After general anesthesia induction, the patients were placed in the deep Trendelenburg position (at least 25°-45° upside down). | Other | Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position. |
Primary outcome
Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury.
Time frame: The duration of the measurement was defined as during the surgery.
Console time ( minute) indicates the restrictive fluid therapy time, prostatic resection, and prostatic urethra anastomosis time.
11 secondary outcomes
Stroke volume variation (SVV) was measured for evaluation of volume status
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Pulse pressure variation (PPV) was measured for evaluation of volume status
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac power output (CPO) was measured for evaluation of cardiac power reserve
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Cardiac index (CI) was measured for evaluating cardiac flow
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Dp/Dt was measured to assess cardiac systolic function
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Mean arterial pressure (MAP) was measured for evaluating perfusion pressure
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Heart rate (HR) was measured for evaluating heart ritm
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
Arterial elastance ( Ea) was measured for evaluation of cardiac afterload and arterial ton
Time frame: The duration of the measurement was defined from one minute before induction to the end of the surgery
The Kidney Disease: Improving Global Outcomes (KDIGO) criteria were used for the definition and staging of acute kidney injury .
Time frame: The duration of the measurement was defined from the end of the surgery to the 3 days after 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 2 Feb 2024.
- Background: PubMed 26844486Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.
- Background: PubMed 27576693Sudfeld S, Leyh-Bannurah SR, Budaus L, Graefen M, Reese PC, von Breunig F, Reuter DA, Saugel B. Impact of perioperative administration of 6 % hydroxyethyl starch 130/0.4 on serum cystatin C-derived renal function after radical prostatectomy: a single-centre retrospective study. BMC Anesthesiol. 2016 Aug 30;16(1):69. doi: 10.1186/s12871-016-0236-8.
- Background: PubMed 21233502Lestar M, Gunnarsson L, Lagerstrand L, Wiklund P, Odeberg-Wernerman S. Hemodynamic perturbations during robot-assisted laparoscopic radical prostatectomy in 45 degrees Trendelenburg position. Anesth Analg. 2011 Nov;113(5):1069-75. doi: 10.1213/ANE.0b013e3182075d1f. Epub 2011 Jan 13.
- Results publication: PubMed 36383279Emir NS, Akyol D, Sabaz MS, Karadag S. Robotic assited perineal prostatectomy (RAPP) as a new era for anesthesiology: It's effects on hemodynamic parameters and respiratory mechanics. J Robot Surg. 2023 Jun;17(3):933-940. doi: 10.1007/s11701-022-01482-x. Epub 2022 Nov 16.
- Results publication: PubMed 24128839Valdivieso RF, Hueber PA, Zorn KC. Robot assisted radical prostatectomy: how I do it. Part I: Patient preparation and positioning. Can J Urol. 2013 Oct;20(5):6957-61.
- Results publication: PubMed 33819496Karaveli A, Kavakli AS, Cakin O, Aykal G, Yildiz A, Ates M. Comparison of plasma neutrophil gelatinase-associated lipocalin (NGAL) levels after robot-assisted laparoscopic and retropubic radical prostatectomy: an observational study. Braz J Anesthesiol. 2022 Jan-Feb;72(1):21-28. doi: 10.1016/j.bjane.2021.03.003. Epub 2021 Apr 2.
- Results publication: PubMed 33020097Pawlik MT, Prasser C, Zeman F, Harth M, Burger M, Denzinger S, Blecha S. Pronounced haemodynamic changes during and after robotic-assisted laparoscopic prostatectomy: a prospective observational study. BMJ Open. 2020 Oct 5;10(10):e038045. doi: 10.1136/bmjopen-2020-038045.
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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.
Fevzi Toraman, M.D. study director
Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
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 Acute Kidney Injury and Hemodynamic Instability, run by Acibadem University 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 3 inclusion and 7 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 2 Feb 2024. 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?
Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury. (time frame: The duration of the measurement was defined as during the surgery.). 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 NCT06000098, which also lists 7 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 2 Feb 2024.