NCT05478564

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

July 26, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 13, 2025

Status Verified

November 1, 2022

Enrollment Period

1 year

First QC Date

July 26, 2022

Last Update Submit

March 10, 2025

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • Global time spent in hypotension <10%

    Hypotension=mean arterial pressure \<65 mmHg for at least 1 minute

    Intraoperative period

Secondary Outcomes (2)

  • Time Weighted Average (TWA) of Area Under the Threshold <0.4 mmHg

    Intraoperative period

  • Incidence of hypotensive events/patient < 8

    Intraoperative period

Interventions

Intraoperative fluids and vasoactive drugs management protocolOTHER

Limitation of hypotensive events during open surgery for abdominal aorta repair

Also known as: In case of >20% ignored protocol (poor adherence), patient will be excluded

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults submitted to open surgery due to abdominal aorta repair

You may qualify if:

  • Adults patients undergoing abdominal aorta open surgical repair

You may not qualify if:

  • Emergent/urgent operation
  • Age \<18 years
  • Pregnancy
  • Intra-operative blood loss \> or = 3000ml

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanitas Clinical and Research center

Rozzano, Milan, 20089, Italy

Location

Related Publications (1)

  • 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.

    PMID: 39948674DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 26, 2022

First Posted

July 28, 2022

Study Start

July 26, 2022

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

March 13, 2025

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)