Hemodynamic InstabilityHEMASNCT05478564
Hemodynamic Monitoring During Abdominal Aortic Surgery
An observational study of Hemodynamic Instability, run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Intraoperative fluids and vasoactive drugs management protocol
- How many people
- 63 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jul 2022to 31 Jul 2023
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adults submitted to open surgery due to abdominal aorta repair
Who may be able to join
- Adults patients undergoing abdominal aorta open surgical repair
Who cannot join
- Emergent/urgent operation
- Age <18 years
- Pregnancy
- Intra-operative blood loss > or = 3000ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence
Read the detailed description
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.
The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.
Primary endpoint: Global time spent in hypotension <10%.
Secondary Endpoints:
- Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
- Incidence of hypotensive events/patient < 8 (including the expected hypotensive events due to the aortic clamping and unclamping)
- Conditions
- Hemodynamic Instability
- Being tested
- Intraoperative fluids and vasoactive drugs management protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative fluids and vasoactive drugs management protocolOther
Also called In case of >20% ignored protocol (poor adherence), patient will be excluded
Limitation of hypotensive events during open surgery for abdominal aorta repair
What is being measured
The primary outcome is the main question the study is designed to answer.
Global time spent in hypotension <10%
Hypotension=mean arterial pressure <65 mmHg for at least 1 minute
Measured: Intraoperative period
Secondary outcomes (2)
Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
The severity of hypotension during the whole intraoperative surgery
Measured: Intraoperative period
Incidence of hypotensive events/patient < 8
including the expected hypotensive events due to the aortic clamping and unclamping
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start26 Jul 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 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 Hemodynamic InstabilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Giustiniano, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478564
- Sponsor's protocol ID
- HEMAS
- Other IDs
- 3236
- Acronym
- HEMAS
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giustiniano E, Nisi F, Ferrod F, Lionetti G, Viscido C, Reda A, Piccioni F, Buono G, Cecconi M. Intraoperative hemodynamic management in abdominal aortic surgery guided by the Hypotension Prediction Index: the Hemas multicentric observational study. J Anesth Analg Crit Care. 2025 Feb 13;5(1):7. doi: 10.1186/s44158-024-00222-x.
PubMed 39948674
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial
- ClinicalTrials.gov ID
- NCT05478564
- Acronym / sponsor ID
- HEMAS / HEMAS
- Conditions
- Hemodynamic Instability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 28 Jul 2022 (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.
This trial investigates the ability of our istitutional algorithm in maintaining a safe hemodynamics during abdominal aorta open surgery, in terms of limitation of intraoperative hypotension incidence
Detailed description
The present trial includes patients submitted to abdominal aorta open surgery. This type of procedure is very challenging for the hemodynamic management because of the operation per se (during which the surgeon clamp and unclamp the aorta with very significant hemodynamic variations) and because of the altered tone of the vessels due to the general vascular disease such a type of patients is suffering from.
The aim of this study is to verify if the incidence of intraoperative hypotension in terms of severity, lasting and number of episodes, may be reduced by the application of a protocol of hemodynamic management.
Primary endpoint: Global time spent in hypotension <10%.
Secondary Endpoints:
- Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
- Incidence of hypotensive events/patient < 8 (including the expected hypotensive events due to the aortic clamping and unclamping)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults submitted to open surgery due to abdominal aorta repair
Key inclusion criteria (1 listed)
- Adults patients undergoing abdominal aorta open surgical repair
Key exclusion criteria (4 listed)
- Emergent/urgent operation
- Age <18 years
- Pregnancy
- Intra-operative blood loss > or = 3000ml
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 |
|---|---|---|
| Intraoperative fluids and vasoactive drugs management protocolAlso: In case of >20% ignored protocol (poor adherence), patient will be excludedLimitation of hypotensive events during open surgery for abdominal aorta repair | Other | – |
Primary outcome
Global time spent in hypotension <10%
Time frame: Intraoperative period
Hypotension=mean arterial pressure <65 mmHg for at least 1 minute
2 secondary outcomes
Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg
Time frame: Intraoperative period
Incidence of hypotensive events/patient < 8
Time frame: Intraoperative period
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 13 Mar 2025.
- Derived from this study: PubMed 39948674Giustiniano E, Nisi F, Ferrod F, Lionetti G, Viscido C, Reda A, Piccioni F, Buono G, Cecconi M. Intraoperative hemodynamic management in abdominal aortic surgery guided by the Hypotension Prediction Index: the Hemas multicentric observational study. J Anesth Analg Crit Care. 2025 Feb 13;5(1):7. doi: 10.1186/s44158-024-00222-x.
- 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.
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?
An observational study of Hemodynamic Instability, run by Humanitas Clinical and Research Center 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 4 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 13 Mar 2025. 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. 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?
Global time spent in hypotension <10% (time frame: Intraoperative period). 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 NCT05478564, 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 13 Mar 2025.