Hypotension Prediction Effect on AKI

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04994639
• Other study ID #: 2021-06-002
• Status: Completed
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: June 27, 2023

Study information

• Verified date: September 2023
• Source: Ewha Womans University Mokdong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University Mokdong Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute kidney injury	Occurrence of acute kidney injury after radical cystectomy	Seven day after the operation
Secondary	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	From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Secondary	Hypotension prediction index	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