Hypotension Prediction Effect on AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2023-06-27

Brief Summary

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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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Detailed Description

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Conditions

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Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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HPI group

Managing intraoperative hemodynamic condition under the HPI guidance

Group Type EXPERIMENTAL

BP management with HPI guidance

Intervention Type 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.

Standard care group

Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No