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Completed

NCT Number: NCT04994639

Hypotension Prediction Effect 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 radical cystectomy. 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

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms 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 radical cystectomy with neobladder reconstruction
  • Patients undergoing radical cystectomy with ileal conduit urinary diversion

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 radical cystectomy

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

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 Radical Cystectomy

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2021
Registry last updated
Sep 21, 2023

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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