Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy

Conditions
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Acute Kidney Injury, Hemodynamic Instability

Intervention / Treatment
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* Other: Restrictive fluid therapy


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.<br>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 | Other: Restrictive fluid therapy<br>* 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).<br>* Other names: Trendelenburg position.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | The duration of the measurement was defined as during the surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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. | The duration of the measurement was defined from the end of the surgery to the 3 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic-assisted laparoscopic prostatectomy, Acute kidney injury, Restrictive fluid therapy, Pressure recording analytical method