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Completed

NCT Number: NCT06000098

Consol Time and Acute Kidney Injury in Robotic-assisted 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).

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemodynamic Instability Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–100 year

Sex eligibility

Male

Study type

Observational

Primary location

Acibadem Altunizade Hospital

Istanbul, 31190, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Restrictive Fluid Therapy

Other

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 names: Trendelenburg position.

Primary outcomes

  1. 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

  1. 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

    Stroke volume variation (SVV,%), was monitored using the pressure recording analytic method. SVV is a parameter used to asses cardiac preload and fluid responsiveness.

  2. 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

    Pulse pressure variation (PPV,%) was monitored using the pressure recording analytic method. PPV is a parameter used to asses cardiac preload and fluid responsiveness

  3. 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 power output (CPO, Watt) was monitored using the pressure recording analytic method. CPO is a parameter used to asses cardiac reserve

  4. 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

    Cardiac index (CI, L/min/m2), was monitored using the pressure recording analytic method. CI is a parameter used to asses cardiac stroke volume.

  5. 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

    Dp/Dt(mmHg/msn), was monitored using the pressure recording analytic method. Dp/Dt is a parameter used to asses cardiac contractility.

  6. 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

    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

  7. 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

    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

  8. 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

    Mean arterial pressure (MAP, mm/Hg) was monitored using the pressure recording analytic method. MAP is a parameter used to assess organ perfusion

  9. 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

    Heart rate( HR, bpm) was monitored using the pressure recording analytic method. HR is a parameter used to assess the cardiac rate

  10. 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

    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

  11. 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

    KDIGO criteria ( stage) classify acute kidney injury based on changes in serum creatinine levels and urine output.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 21, 2023
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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