Hemodynamic Optimization Based on a Dynamic Elastance Protocol

March 23, 2024 updated by: RUSSO ANDREA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Intraoperative Fluid Optimization Based on a Dynamic Elastance Protocol During Major Abdominal Surgery: a Randomised Control Trial

In this study investigators explore the effects of a dynamic elastance guided protocol compared to a stroke volume variation fluid therapy on lactate levels during major abdominal surgery. Hence investigators created two groups: in the intervention group fluids are given in fluid-responders (SVV > 13%) based on high value of dynamic elastance (ie. Eadyn > 0.9). In the standard group fluids are administered when SVV > 13%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

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

  • Italy
      • Rome, Italy, 00166
        • Andrea Russo

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: patients enrolled for major abdominal surgery

-

Exclusion Criteria:

  1. end-stage renal disease
  2. severe heart dysfunction
  3. heart rhythm alterations

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: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: intervention
Behavioral: Elastance Group
Fluids are given based on dynamic elastane value

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lactate levels
Time Frame: at the end of surgery
at 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

Investigators

  • Principal Investigator: Andrea Russo, MD, Fondazione Policlinico Universitario Agostino Gemelli

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)

February 25, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

December 25, 2021

First Submitted That Met QC Criteria

December 25, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ID3724

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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