NCT05187273

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

December 25, 2021

Last Update Submit

March 23, 2024

Conditions

Fluid Management

Outcome Measures

Primary Outcomes (1)

  • lactate levels

    at the end of surgery

Study Arms (2)

intervention

EXPERIMENTAL
Behavioral: Elastance Group

control

NO INTERVENTION

Interventions

Elastance GroupBEHAVIORAL

Fluids are given based on dynamic elastane value

intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • end-stage renal disease
  • severe heart dysfunction
  • heart rhythm alterations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andrea Russo

Rome, 00166, Italy

Location

Related Publications (1)

  • 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.

    PMID: 40070308DERIVED

Study Officials

  • andrea russo, MD

    Fondazione Policlinico Universitario Agostino Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2021

First Posted

January 11, 2022

Study Start

February 25, 2021

Primary Completion

August 30, 2022

Study Completion

December 30, 2023

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations

IT(1)