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RecruitingNCT06932484DELTAUpdated Jul 31, 2025

Delta Variation to Guide Hemodynamic Optimization

An interventional study of parameters in Hemodynamic MAP Stability, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-31.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

intraoperative hemodynamic optimization will be based on the percentage of variation of the parameters

02

Conditions studied

  • Hemodynamic MAP Stability
03

In context

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: All patients > 18 years old scheduled for major abdominal

Exclusion Criteria:

Body Mass Index > 35 kg/m2 Pregnancy Refusal to sign written informed consent Urgent and/or emergency surgery

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    delta

    in this group the trigger for any intervention will be the delta variation of the hemodynamic parameters showed in the monitoring platform

    Procedure: parameters

  • No intervention
    standard

    in this group hemodynamics will be managed by using the hypotension prediction index

Interventions

  • Procedureparameters

    during surgery hemodynamic will be optimized based on percentage variation of different variables

06

What researchers measure

Primary outcomes

  1. time weighted average of mean arterial pressure

    we will avoid hypotensive episodes by using a predictive approach and then calculate the TWA-MAP \< 65 mmHg

    Time frame: the end of surgery

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06932484
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
RUSSO ANDREA (MD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Apr 17, 2025
Start date
Jun 1, 2025
Primary completion
May 1, 2026 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Jul 31, 2025

Study contacts

andrea russo, physician
Contact
andrea.russo@policlinicogemelli.it
+39-06-30153212

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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