HPI Effect in Robotic Urological Surgery on AKI

Study Overview
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Brief Summary
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It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after robot-assisted urological surgery. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).

Official Title
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Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Robotic-assisted Urologic Surgery

Conditions
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Prostate Cancer, Renal Cancer, Urologic Diseases

Intervention / Treatment
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* Device: BP management with HPI guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≧ 19 Patients undergoing robot-assisted urological surgery Exclusion Criteria: Unable to voluntarily give consent Unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary LN dissection, AV fistula for renal replacement therapy, or abnormal Allen's test.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPI<br>Managing intraoperative hemodynamic condition under the HPI guidance | Device: BP management with HPI guidance<br>* The hemodynamic condition of the HPI group will be managed by HPI guidance which is derived by arterial pressure waveform information, including Eadyn, SVV, dP/dt.<br>|
| No Intervention: Control<br>Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury | Occurrence of acute kidney injury after robotic urological surgery | Seven day after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth and duration of hypotension | Depth and duration of hypotension will be assessed by calculating time weighted average (TWA) of hypotension under mean arterial pressure under 65 mmHg during the operation | From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia | 
| Hypotension prediction index | Time weighted average of hypotension prediction index during the operation | From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia | 
| Biomarkers | Biomarkers for early detection of AKI - Cystacin C, KIM-1 | Baseline, immediate postop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic