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Recruiting NCT06984302

A PREDICTIVE ALGORITHM IN AORTIC SURGERY

No phase Interventional Hemodynamic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: proactive therapy.
Who it may be relevant to
Registry conditions: Hemodynamic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

HYPOTENSION PREDICTION INDEX FOR HEMODYNAMIC OPTIMIZATION IN MAJOR VASCULAR SURGERY

Overview

We will enroll patients scheduled for abdominal aortic aneurysm repair and divide in two groups; in the control group the hemodynamic optimization will be made based on standard cardiovascular parameters showed in the Hemosphere platform. In the interventional group the hemodynamic optimization will be made based on the hypotension prediction index.

Interventions

  • Other proactive therapy
    drugs and fluids will be given based on the hypotension prediction index

Primary outcome measures

  • time weighted average of mean arterial presure under 65 mmHg [Time frame: at the end of surgery]

Eligibility criteria

Inclusion criteria

  • planned aortic surgery acceptance of written informed consent

Exclusion criteria

  • body mass index > 35 kg/m2
  • atrial fibrillation
  • urgent surgery
  • end-stage renal disease
  • pregnancy
  • refusal of the consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli — Rome

Identifiers

NCT: NCT06984302 · 7458

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗