Intraoperative HypotensionNCT04872504
Hypotension Prediction Index in Patients Undergoing Liver Transplantation
A study testing Acumen HPI-enabled EV1000 screen in people with Intraoperative Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Intraoperative Hypotension
- What is being tested?
- Acumen HPI-enabled EV1000 screen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2021to 1 Feb 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age ≥ 20 years;
- Scheduled liver transplantation
- Planned pressure monitoring with an arterial line;
- General anesthesia
Who cannot join
- Contraindication for invasive blood pressure monitoring
- End-staged renal disease
- pre-operative MAP <65 mmHg
- Severe heart failure
- Severe cardiac shunt
- Severe aortic stenosis
- Severe atrial fibrillation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan City, 333
Yung Fong Tsai, PHD
About this study
Official title: Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation
A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.
- Conditions
- Intraoperative Hypotension
- Being tested
- Acumen HPI-enabled EV1000 screen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen HPI-enabled EV1000 screenDevice
Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension
| Study group | Role | What they receive |
|---|---|---|
| Acumen HPI-enabled EV1000 screen | Experimental | Acumen HPI-enabled EV1000 screen Receives: Device: Acumen HPI-enabled EV1000 screen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accurate hypotension prediction of EV1000 system
Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min
Measured: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.
Incidence of intraoperative hypotension
Frequency, duration of intraoperative hypotension, which defined as MAP < 65 mmHg at least 1 min
Measured: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
Severity of intraoperative hypotension
MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) < 65 mmHg
Measured: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
Secondary outcomes (3)
Hospital stay and ICU stay
The incidence and severity of intraoperative hypotension correlate with patient's hospital stay and ICU stay
Measured: Days from admission to discharge, assessed up to 1 month
Mortality after surgery
The incidence and severity of intraoperative hypotension correlate with patient's mortality
Measured: Days from admission to discharge, assessed up to 1 month
Adverse effects
The incidence and severity of hypotension correlate with the adverse effects like acute liver failure, acute kidney injury and acute myocardial injury
Measured: Days from admission to discharge, assessed up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872504
- Sponsor's protocol ID
- Hypotension prediction index
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yeh BH, Lu YC, Liu FC, Tsai HI, Lin CC, Chen CY, Lee WC, Tsai YF. Predictive value of Hypotension Prediction Index in liver transplantation: a prospective study. Minerva Anestesiol. 2026 May;92(5):435-445. doi: 10.23736/S0375-9393.25.19432-7. Epub 2026 Mar 23.
PubMed 41870962
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Hypotension Prediction Index With Invasive Arterial Pressure Waveform in Liver Transplantation
- ClinicalTrials.gov ID
- NCT04872504
- Acronym / sponsor ID
- Hypotension prediction index
- Conditions
- Intraoperative Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 4 May 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.
A prospective, open-label and single-center study to determine whether the use of Acumen Hypotension Prediction Index software predicts the occurrence of hypotension.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acumen HPI-enabled EV1000 screen | Experimental | Device: Acumen HPI-enabled EV1000 screenAcumen HPI-enabled EV1000 screen |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent
- Age ≥ 20 years;
- Scheduled liver transplantation
- Planned pressure monitoring with an arterial line;
- General anesthesia
Key exclusion criteria (7 listed)
- Contraindication for invasive blood pressure monitoring
- End-staged renal disease
- pre-operative MAP <65 mmHg
- Severe heart failure
- Severe cardiac shunt
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 |
|---|---|---|
| Acumen HPI-enabled EV1000 screenAcumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension | Device | Acumen HPI-enabled EV1000 screen |
Primary outcome
Accurate hypotension prediction of EV1000 system
Time frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.
Analyze the actual incidence of hypotension after HPI alarm more than 85 within 15 min
Incidence of intraoperative hypotension
Time frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
Frequency, duration of intraoperative hypotension, which defined as MAP < 65 mmHg at least 1 min
Severity of intraoperative hypotension
Time frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day
MAP measurements were recorded every 20 s by the EV1000 system from induction to Time-weighted average mean arterial pressure (TWA-MAP) < 65 mmHg
3 secondary outcomes
Hospital stay and ICU stay
Time frame: Days from admission to discharge, assessed up to 1 month
Mortality after surgery
Time frame: Days from admission to discharge, assessed up to 1 month
Adverse effects
Time frame: Days from admission to discharge, assessed up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Derived from this study: PubMed 41870962Yeh BH, Lu YC, Liu FC, Tsai HI, Lin CC, Chen CY, Lee WC, Tsai YF. Predictive value of Hypotension Prediction Index in liver transplantation: a prospective study. Minerva Anestesiol. 2026 May;92(5):435-445. doi: 10.23736/S0375-9393.25.19432-7. Epub 2026 Mar 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen HPI-enabled EV1000 screen in people with Intraoperative Hypotension, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 May 2021. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BO HAN YEH (+886978989006, 100311047@gms.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accurate hypotension prediction of EV1000 system (time frame: MAP measurements of each case were recorded every 20 s by the EV1000 system from induction to the end of surgery, assessed up to 1 day.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872504, which also lists 1 linked publication.
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 4 May 2021.