Hypotension Prediction Effect on AKI

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04994639

Enrollment

120

Registered

2021-08-06

Start date

2021-08-24

Completion date

2023-06-27

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer

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).

Interventions

DEVICEBP 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026