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Completed

NCT Number: NCT05478564

Hemodynamic Monitoring During Abdominal Aortic Surgery

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

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Clinical and Research center

Rozzano, Milan, 20089, Italy

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients undergoing abdominal aorta open surgical repair

Exclusion criteria

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

Treatment and study plan

Intraoperative fluids and vasoactive drugs management protocol

Other

Limitation of hypotensive events during open surgery for abdominal aorta repair

Other names: In case of >20% ignored protocol (poor adherence), patient will be excluded

Primary outcomes

  1. Global time spent in hypotension <10%

    Time frame: Intraoperative period

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

Secondary outcomes

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

    Time frame: Intraoperative period

    The severity of hypotension during the whole intraoperative surgery

  2. Incidence of hypotensive events/patient < 8

    Time frame: Intraoperative period

    including the expected hypotensive events due to the aortic clamping and unclamping

Sponsors and collaborators

Lead sponsor

Humanitas Clinical and Research Center

Other

Registry information

Official study title

INTRAOPERATIVE HEMODYNAMIC MANAGEMENT IN ABDOMINAL AORTIC SURGERY GUIDED BY HYPOTENSION PREDICTION INDEX (HPI) - HEMAS Trial

Acronym: HEMAS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 28, 2022
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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