Hemodynamic Optimization Based on a Dynamic Elastance Protocol

NCT ID: NCT05187273

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-25

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Fluid Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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intervention

Group Type EXPERIMENTAL

Elastance Group

Intervention Type BEHAVIORAL

Fluids are given based on dynamic elastane value

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Elastance Group

Fluids are given based on dynamic elastane value

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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RUSSO ANDREA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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andrea russo, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Locations

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Andrea Russo

Rome, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 40070308 (View on PubMed)

Other Identifiers

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ID3724

Identifier Type: -

Identifier Source: org_study_id

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