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Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06000098
Enrollment
42
Registered
2023-08-21
Start date
2023-09-25
Completion date
2023-10-16
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Hemodynamic Instability

Keywords

Robotic-assisted laparoscopic prostatectomy, Acute kidney injury, Restrictive fluid therapy, Pressure recording analytical method

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.

Interventions

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).

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No

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,

Design outcomes

Primary

MeasureTime frameDescription
Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury.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.

Secondary

MeasureTime frameDescription
Pulse pressure variation (PPV) was measured for evaluation of volume statusThe duration of the measurement was defined from one minute before induction to the end of the surgeryPulse pressure variation (PPV,%) was monitored using the pressure recording analytic method. PPV is a parameter used to asses cardiac preload and fluid responsiveness
Cardiac power output (CPO) was measured for evaluation of cardiac power reserveThe duration of the measurement was defined from one minute before induction to the end of the surgeryCardiac power output (CPO, Watt) was monitored using the pressure recording analytic method. CPO is a parameter used to asses cardiac reserve
Cardiac index (CI) was measured for evaluating cardiac flowThe duration of the measurement was defined from one minute before induction to the end of the surgeryCardiac index (CI, L/min/m2), was monitored using the pressure recording analytic method. CI is a parameter used to asses cardiac stroke volume.
Dp/Dt was measured to assess cardiac systolic functionThe duration of the measurement was defined from one minute before induction to the end of the surgeryDp/Dt(mmHg/msn), was monitored using the pressure recording analytic method. Dp/Dt is a parameter used to asses cardiac contractility.
Systolic arterial pressure (SAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgerySystolic 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
Stroke volume variation (SVV) was measured for evaluation of volume statusThe duration of the measurement was defined from one minute before induction to the end of the surgeryStroke volume variation (SVV,%), was monitored using the pressure recording analytic method. SVV is a parameter used to asses cardiac preload and fluid responsiveness.
Mean arterial pressure (MAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgeryMean arterial pressure (MAP, mm/Hg) was monitored using the pressure recording analytic method. MAP is a parameter used to assess organ perfusion
Heart rate (HR) was measured for evaluating heart ritmThe duration of the measurement was defined from one minute before induction to the end of the surgeryHeart rate( HR, bpm) was monitored using the pressure recording analytic method. HR is a parameter used to assess the cardiac rate
Arterial elastance ( Ea) was measured for evaluation of cardiac afterload and arterial tonThe duration of the measurement was defined from one minute before induction to the end of the surgeryEa ((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 Kidney Disease: Improving Global Outcomes (KDIGO) criteria were used for the definition and staging of acute kidney injury .The duration of the measurement was defined from the end of the surgery to the 3 days after surgeryKDIGO criteria ( stage) classify acute kidney injury based on changes in serum creatinine levels and urine output.
Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressureThe duration of the measurement was defined from one minute before induction to the end of the surgeryDiastolic 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026