Hypotension Prediction Effect on AKI

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: BP management with HPI guidance

• Registration Number: NCT04994639
• Lead Sponsor: Ewha Womans University Mokdong Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-06
• Study Start: 2021-08-24
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-17
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Age ≧ 19
• Patients undergoing radical cystectomy with neobladder reconstruction
• Patients undergoing radical cystectomy with ileal conduit urinary diversion

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPI group	BP management with HPI guidance	Managing intraoperative hemodynamic condition under the HPI guidance

Primary Outcome Measures

Name	Time	Method
Acute kidney injury	Seven day after the operation	Occurrence of acute kidney injury after radical cystectomy

Secondary Outcome Measures

Name	Time	Method
Hypotension prediction index	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
Depth and duration of hypotension	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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of