Hypotension Prediction Effect on AKI

NCT04994639 | Completed

• 1 other identifier: 2021-06-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  Occurrence of acute kidney injury after radical cystectomy

  Seven day after the operation

Secondary Outcomes (2)

• Depth and duration of hypotension

  From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia

• Hypotension prediction index

  From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia

Study Arms (2)

HPI group

EXPERIMENTAL

Managing intraoperative hemodynamic condition under the HPI guidance

Device: BP management with HPI guidance

Standard care group

NO INTERVENTION

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

Interventions

BP management with HPI guidance 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.

HPI group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead

Study Sites (1)

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sooyoung Cho, MD, PhD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 6, 2021
• Study Start: August 24, 2021
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)