Hypotension Prediction Effect on AKI

Sponsor

Ewha Womans University Mokdong Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04994639

Collaborator

(none)

120

Enrollment

Location

Arms

18.4

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Device: BP management with HPI guidance	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Mar 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HPI group Managing intraoperative hemodynamic condition under the HPI guidance	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.
No Intervention: Standard care group Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen)

Arm

Intervention/Treatment

Experimental: HPI group

Managing intraoperative hemodynamic condition under the HPI guidance

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.

No Intervention: Standard care group

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

Outcome Measures

Primary Outcome Measures

Acute kidney injury [Seven day after the operation]
Occurrence of acute kidney injury after radical cystectomy

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ewha Womans University Mokdong Hospital	Seoul		Korea, Republic of	07985

Sponsors and Collaborators

Ewha Womans University Mokdong Hospital

Investigators

Principal Investigator: Sooyoung Cho, MD, PhD, Ewha Womans University Mokdong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sooyoung Cho, Assistant Professor, Ewha Womans University Mokdong Hospital

ClinicalTrials.gov Identifier:

NCT04994639

Other Study ID Numbers:

2021-06-002

First Posted:

Aug 6, 2021

Last Update Posted:

Aug 17, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Aug 17, 2021