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Clinical Trials/NCT06000098
NCT06000098
Completed
Not Applicable

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

Acibadem University1 site in 1 country42 target enrollmentSeptember 25, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Acibadem University
Enrollment
42
Locations
1
Primary Endpoint
Console time was measured for evaluating the effect of restrictive fluid therapy and prostatic urethra anastomosis time on the development of acute kidney injury.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 25, 2023
End Date
October 16, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
Acibadem University
Responsible Party
Sponsor

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,

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Stroke volume variation (SVV) was measured for evaluation of volume status(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(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(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(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(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(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(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(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(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 .(The duration of the measurement was defined from the end of the surgery to the 3 days after surgery)
  • Diastolic arterial pressure (DAP) was measured for evaluating perfusion pressure(The duration of the measurement was defined from one minute before induction to the end of the surgery)

Study Sites (1)

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