Delta Variation to Guide Hemodynamic Optimization (DELTA)

July 30, 2025 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

A NEW APPROACH IN THE MANAGEMENT OF INTRAOPERATIVE ARTERIAL HYPOTENSION BASED ON DELTA VARIATION OF HEMODYNAMIC PARAMETERS: A RANDOMISED CLINICAL TRIAL

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
during surgery hemodynamic will be optimized based on percentage variation of different variables
No Intervention: standard
in this group hemodynamics will be managed by using the hypotension prediction index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time weighted average of mean arterial pressure
Time Frame: the end of surgery
we will avoid hypotensive episodes by using a predictive approach and then calculate the TWA-MAP < 65 mmHg
the end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 10, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 7428 (Other Identifier: New York State Psychiatric Institute Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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