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Completed

NCT Number: NCT06051162

HPI Effect in Robotic Urological Surgery on AKI

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).

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Key information

Conditions

Prostate Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Renal Cancer Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

BP management with HPI guidance

Device

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.

Primary outcomes

  1. Acute kidney injury

    Time frame: Seven day after the operation

    Occurrence of acute kidney injury after robotic urological surgery

Secondary outcomes

  1. Depth and duration of hypotension

    Time frame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia

    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

  2. Hypotension prediction index

    Time frame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia

    Time weighted average of hypotension prediction index during the operation

  3. Biomarkers

    Time frame: Baseline, immediate postop

    Biomarkers for early detection of AKI - Cystacin C, KIM-1

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Sep 8, 2026

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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