Hypotension Prediction Effect on AKI

September 17, 2023 updated by: Sooyoung Cho, Ewha Womans University Mokdong Hospital

Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Radical Cystectomy

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07985
        • Ewha Womans University Mokdong Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HPI group
Managing intraoperative hemodynamic condition under the HPI guidance
Device: BP management with HPI guidance
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.
No Intervention: Standard care group
Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: Seven day after the operation
Occurrence of acute kidney injury after radical cystectomy
Seven day after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
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
From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Investigators

  • Principal Investigator: Sooyoung Cho, MD, PhD, Ewha Womans University Mokdong Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2021

Primary Completion (Actual)

June 27, 2023

Study Completion (Actual)

June 27, 2023

Study Registration Dates

First Submitted

August 3, 2021

First Submitted That Met QC Criteria

August 3, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-06-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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