Clinical trial NCT06000098: Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy
Official title: Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Hemodynamic Instability
Keywords: Robotic-assisted laparoscopic prostatectomy
Acute kidney injury
Restrictive fluid therapy
Pressure recording analytical method
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with ASA (American Society Of Anesthesiology) physical status 1-3 who underwent RALP with restrictive fluid therapy during console period

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients with American Society Of Anesthesiology physical status 1-3
* Underwent Robotic-assisted laparoscopic prostatectomy
* Underwent restrictive fluid therapy during the console period

Exclusion Criteria:

* 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,

Primary outcomes:
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.
timeFrame: The duration of the measurement was defined as during the surgery.
Secondary outcomes:
measure: Stroke volume variation (SVV) was measured for evaluation of volume status
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Pulse pressure variation (PPV) was measured for evaluation of volume status
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Cardiac power output (CPO) was measured for evaluation of cardiac power reserve
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Cardiac index (CI) was measured for evaluating cardiac flow
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Dp/Dt was measured to assess cardiac systolic function
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Systolic arterial pressure (SAP) was measured for evaluating perfusion pressure
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Mean arterial pressure (MAP) was measured for evaluating perfusion pressure
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Heart rate (HR) was measured for evaluating heart ritm
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: Arterial elastance ( Ea) was measured for evaluation of cardiac afterload and arterial ton
timeFrame: The duration of the measurement was defined from one minute before induction to the end of the surgery
measure: The Kidney Disease: Improving Global Outcomes (KDIGO) criteria were used for the definition and staging of acute kidney injury .
timeFrame: The duration of the measurement was defined from the end of the surgery to the 3 days after surgery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hospital
Study officials:
affiliation: Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology
name: Fevzi Toraman, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Sudfeld 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.
citation: Lestar 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.
citation: Emir 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.
citation: Valdivieso 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.
citation: Karaveli 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.
citation: Pawlik 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.