Hypotension During SurgeryHPI in RARPNCT06535464
Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy
A study testing Hypotension Prediction Index and No Hypotension Prediction Index in people with Hypotension During Surgery, run by University of Foggia at 1 site in Italy.
Trial summary
Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Hypotension Prediction Index and No Hypotension Prediction Index
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 1 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all consecutive patients undergoing RARP; American Society of Anaesthesiology (ASA) SCORE I-III
Who cannot join
- Body Mass Index (BMI) of 18.5 to 35, uncontrolled arrhythmias, myocardial infarction or ischemic/hemorrhagic stroke in the last 6 months, III/IV stage Global Initiative for Chronic Obstructive Lung Disease, pulmonary fibrosis, contraindication to radial artery cannulation.
Trial locations and contacts
1 site in 1 country.
About this study
Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. The aim of this prospective randomised study is to evaluate the cumulative amount of intraoperative arterial hypotension episodes in patients undergoing RARP managed by GDT protocol guided or not by HPI algorithm
- Conditions
- Hypotension During Surgery
- Being tested
- Hypotension Prediction Index, No Hypotension Prediction Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypotension Prediction IndexDevice
Fluid management guided by Hypotension Prediction Index
No Hypotension Prediction IndexDevice
Fluid management not guided by Hypotension Prediction Index
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed therapy guided by Hypotension Prediction Index algorithm | Active comparator | Not described Receives: Device: Hypotension Prediction Index |
| Goal-directed therapy alone | Sham comparator | Not described Receives: Device: No Hypotension Prediction Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative amount of time spent in Hypotension
the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2022
- Primary completion30 Apr 2023
- Study completion1 Sep 2023
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 Hypotension During SurgeryStudies 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
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cotoia Antonella, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535464
- Sponsor's protocol ID
- 135/C.E. 2021
- Acronym
- HPI in RARP
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not allowed in the consent form
Publications
Cotoia A, Discenza A, Rauseo M, Matella M, Caggianelli G, Ciaramelletti R, Mirabella L, Cinnella G. Intraoperative hypotension during robotic-assisted radical prostatectomy: A randomised controlled trial comparing standard goal-directed fluid therapy with hypotension prediction index-guided goal-directed fluid therapy. Eur J Anaesthesiol. 2025 Oct 1;42(10):916-923. doi: 10.1097/EJA.0000000000002211. Epub 2025 Jun 9.
PubMed 40493027
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypotension Prediction Index (HPI) in Patients Undergoing Robotic Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT06535464
- Acronym / sponsor ID
- HPI in RARP / 135/C.E. 2021
- Conditions
- Hypotension During Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 Aug 2024 (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.
Robot assisted radical prostatectomy (RARP) is the leader in robotic treatment for prostate cancer. Goal-directed therapy (GDT) is the approach used, but HPI, a machine learning algorithm analysing arterial waveforms, might offer additional benefits. The aim of this prospective randomised study is to evaluate the cumulative amount of intraoperative arterial hypotension episodes in patients undergoing RARP managed by GDT protocol guided or not by HPI algorithm
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed therapy guided by Hypotension Prediction Index algorithm | Active comparator | Device: Hypotension Prediction Index |
| Goal-directed therapy alone | Sham comparator | Device: No Hypotension Prediction Index |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all consecutive patients undergoing RARP; American Society of Anaesthesiology (ASA) SCORE I-III
Key exclusion criteria (1 listed)
- Body Mass Index (BMI) of 18.5 to 35, uncontrolled arrhythmias, myocardial infarction or ischemic/hemorrhagic stroke in the last 6 months, III/IV stage Global Initiative for Chronic Obstructive Lung Disease, pulmonary fibrosis, contraindication to radial artery cannulation.
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 |
|---|---|---|
| Hypotension Prediction IndexFluid management guided by Hypotension Prediction Index | Device | Goal-directed therapy guided by Hypotension Prediction Index algorithm |
| No Hypotension Prediction IndexFluid management not guided by Hypotension Prediction Index | Device | Goal-directed therapy alone |
Primary outcome
cumulative amount of time spent in Hypotension
Time frame: intraoperative
the cumulative amount of intraoperative hypotension, measured by Time Weighted Average (TWA) of Mean Arterial Pressure (MAP) below 65 mmHg
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 2 Aug 2024.
- Derived from this study: PubMed 40493027Cotoia A, Discenza A, Rauseo M, Matella M, Caggianelli G, Ciaramelletti R, Mirabella L, Cinnella G. Intraoperative hypotension during robotic-assisted radical prostatectomy: A randomised controlled trial comparing standard goal-directed fluid therapy with hypotension prediction index-guided goal-directed fluid therapy. Eur J Anaesthesiol. 2025 Oct 1;42(10):916-923. doi: 10.1097/EJA.0000000000002211. Epub 2025 Jun 9.
- Individual participant dataSharing planned: No. It is not allowed in the consent form
Related trials for Hypotension During Surgery
Not yet recruitingPhase 4
OB VEGA-Phenylephrine vs Norepinephrine Outcomes
Hypotension During Surgery, Cesarean Birth
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
Recruiting
Effects of Different MAP Targets on Ocular Perfusion and Optic Nerve Microvasculature During Rhinoplasty
Controlled Hypotension for Nasal Surgeries
Not yet recruitingObservational study
Carotid Artery Blood Flow, Blood Pressure, and Cardiac Output During Anesthesia in Children Aged 0-5 Years
Hypotension (MeSH: D007022)
Not yet recruiting
Feasibility Study of E-Fusion Vasopressor Titration-Assist During Multi-Level Spine Surgery
Intraoperative Hypotension
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypotension Prediction Index and No Hypotension Prediction Index in people with Hypotension During Surgery, run by University of Foggia at 1 site in Italy.
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 1 inclusion and 1 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 2 Aug 2024. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
cumulative amount of time spent in Hypotension (time frame: intraoperative). 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 NCT06535464, 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 2 Aug 2024.