Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

• ClinicalTrials.gov Identifier: NCT06000098
• Recruitment Status: Completed
• First Posted: August 21, 2023
• Last Update Posted: February 2, 2024
• Sponsor: Acibadem University
• Information provided by (Responsible Party): Acibadem University

Study Description

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).

Condition or disease	Intervention/treatment
Acute Kidney Injury; Hemodynamic Instability	Other: Restrictive fluid therapy

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 42 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Effect of Console Time on the Development of Acute Kidney Injury in Robotic-assisted Laparoscopic Prostatectomy
• Actual Study Start Date: September 25, 2023
• Actual Primary Completion Date: October 15, 2023
• Actual Study Completion Date: October 16, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Patients undergoing robotic-assisted laparoscopic prostatectomy in deep Trendelenburg position.; 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; 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 Name: Trendelenburg position.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• 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

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,

Contacts and Locations

Locations

Turkey

Acibadem Altunizade Hospital

Istanbul, Turkey, 31190

Sponsors and Collaborators

Acibadem University

Investigators

• Study Director: Fevzi Toraman, M.D.; Acibadem Mehmet Ali Aydinlar University School of Medicine, Department of Anesthesiology

More Information

Publications of Results:

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.

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.

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.

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.

Other Publications:

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.

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.

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.

• Responsible Party: Acibadem University
• ClinicalTrials.gov Identifier: NCT06000098
• Other Study ID Numbers: ATADEK 2021-01/2
• First Posted: August 21, 2023
• Last Update Posted: February 2, 2024
• Last Verified: February 2024

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acibadem University:

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

Additional relevant MeSH terms:

Acute Kidney Injury; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases