Bladder CancerNCT04994639
Hypotension Prediction Effect on AKI
A study testing BP management with HPI guidance in people with Bladder Cancer, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- BP management with HPI guidance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Aug 2021to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧ 19
- Patients undergoing radical cystectomy with neobladder reconstruction
- Patients undergoing radical cystectomy with ileal conduit urinary diversion
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Radical Cystectomy
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
- Being tested
- BP management with HPI guidance
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP management with HPI guidanceDevice
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 group | Role | What they receive |
|---|---|---|
| HPI group | Experimental | Managing intraoperative hemodynamic condition under the HPI guidance Receives: Device: BP management with HPI guidance |
| Standard care group | No intervention | Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury
Occurrence of acute kidney injury after radical cystectomy
Measured: Seven day after the operation
Secondary outcomes (2)
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
Measured: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Hypotension prediction index
Time weighted average of hypotension prediction index during the operation
Measured: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start24 Aug 2021
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sooyoung Cho, Ewha Womans University Mokdong Hospital
- Investigators
- Sooyoung Cho, MD, PhD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994639
- Sponsor's protocol ID
- 2021-06-002
- Status last verified
- Sep 2023
- First submitted
- 3 Aug 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Use of Hypotension Prediction System in Prevention of Postoperative Acute Kidney Injury in Radical Cystectomy
- ClinicalTrials.gov ID
- NCT04994639
- Acronym / sponsor ID
- 2021-06-002
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPI group | Experimental | Device: BP management with HPI guidanceManaging intraoperative hemodynamic condition under the HPI guidance |
| Standard care group | No intervention | –Managing intraoperative hemodynamic condition with standard anesthesia care (blinding the HPI monitor screen) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≧ 19
- Patients undergoing radical cystectomy with neobladder reconstruction
- Patients undergoing radical cystectomy with ileal conduit urinary diversion
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BP management with HPI guidanceThe 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. | Device | HPI group |
Primary outcome
Acute kidney injury
Time frame: Seven day after the operation
Occurrence of acute kidney injury after radical cystectomy
2 secondary outcomes
Depth and duration of hypotension
Time frame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Hypotension prediction index
Time frame: From applying HPI (hypotension prediction index) monitor to the arterial line to the end of the anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sooyoung Cho, MD, PhD principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BP management with HPI guidance in people with Bladder Cancer, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: Seven day after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 28 Oct 2026.