Back to resultsHypotension Prediction Effect on AKI
Primary Purpose
Bladder Cancer
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BP management with HPI guidance
Sponsored by
About this trial
This is an interventional prevention trial for Bladder Cancer
Eligibility Criteria
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.
Sites / Locations
- Ewha Womans University Mokdong Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HPI group
Standard care group
Arm Description
Managing intraoperative hemodynamic condition under the HPI guidance
Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)
Outcomes
Primary Outcome Measures
Acute kidney injury
Occurrence of acute kidney injury after radical cystectomy
Secondary Outcome Measures
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
Hypotension prediction index
Time weighted average of hypotension prediction index during the operation
Full Information
NCT ID
NCT04994639
First Posted
August 3, 2021
Last Updated
September 17, 2023
Sponsor
Ewha Womans University Mokdong Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04994639
Brief Title
Hypotension Prediction Effect on AKI
Official Title
Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Radical Cystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2021 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ewha Womans University Mokdong Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HPI group
Arm Type
Experimental
Arm Description
Managing intraoperative hemodynamic condition under the HPI guidance
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)
Intervention Type
Device
Intervention Name(s)
BP management with HPI guidance
Intervention Description
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 Outcome Measure Information:
Title
Acute kidney injury
Description
Occurrence of acute kidney injury after radical cystectomy
Time Frame
Seven day after the operation
Secondary Outcome Measure Information:
Title
Depth and duration of hypotension
Description
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
Time Frame
From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Title
Hypotension prediction index
Description
Time weighted average of hypotension prediction index during the operation
Time Frame
From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sooyoung Cho, MD, PhD
Organizational Affiliation
Ewha Womans University Mokdong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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Hypotension Prediction Effect on AKI
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