Consol Time and Acute Kidney Injury in Robotic-assisted Prostatectomy

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06000098
• Other study ID #: ATADEK 2021-01/2
• Status: Completed
• Start date: September 25, 2023
• Est. completion date: October 16, 2023

Study information

• Verified date: February 2024
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 16, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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,

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hemodynamic Instability
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
Turkey	Acibadem Altunizade Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. 2 — View Citation

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. — View Citation

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/bmj — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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