Hemodynamic Optimization Based on a Dynamic Elastance Pro... | NCT05187273

Studies
Hemodynamic Optimization Based on a Dynamic Elastance Protocol

NCT05187273

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Completed

Last Update Posted

Mar 26, 2024Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Fluid Management

Interventions

Elastance Group

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2021Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Dec 25, 2021

First Submission Date that Met QC Criteria

Dec 25, 2021

First Posted Date

Jan 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2024

Last Update Posted Date

Mar 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

RUSSO ANDREA, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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%.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Experimental		Behavioral: Elastance Group
control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elastance Group	Behavioral	Fluids are given based on dynamic elastane value	intervention

Measure	Description	Time Frame
lactate levels		at the end of surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria: patients enrolled for major abdominal surgery

Exclusion Criteria:

end-stage renal disease
severe heart dysfunction
heart rhythm alterations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
andrea russo, MD	Fondazione Policlinico Universitario Agostino Gemelli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Andrea Russo		Rome		00166	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40070308	Derived	Russo A, Aceto P, Cascarano L, Menga LS, Romano B, Carelli S, Console E, Pugliese F, Cambise C, Fiorillo C, Alfieri S, Antonelli M, Sollazzi L, Dell'Anna AM. A dynamic elastance-based protocol to guide intra-operative fluid management in major abdominal surgery: A randomised clinical trial. Eur J Anaesthesiol. 2025 Aug 1;42(8):727-736. doi: 10.1097/EJA.0000000000002162. Epub 2025 Mar 11.