HPI Effect in Robotic Urological Surgery on AKI

NCT06051162 | Unknown

• 1 other identifier: 2023-02-016-003
• Study Type: interventional
• Target: 124
• 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 robot-assisted urological surgery. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).

Conditions

Prostate Cancer; Renal Cancer; Urologic Diseases

Keywords

Robotic

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  Occurrence of acute kidney injury after robotic urological surgery

  Seven day after the operation

Secondary Outcomes (3)

• 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

• Biomarkers

  Baseline, immediate postop

Study Arms (2)

HPI

EXPERIMENTAL

Managing intraoperative hemodynamic condition under the HPI guidance

Device: BP management with HPI guidance

Control

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

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 robot-assisted urological surgery

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

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Kidney Neoplasms; Urologic Diseases

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Kidney Diseases

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: September 17, 2023
• First Posted: September 22, 2023
• Study Start: November 7, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)