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Hemodynamic Optimization Based on a Dynamic Elastance Protocol

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05187273
Enrollment
46
Registered
2022-01-11
Start date
2021-02-25
Completion date
2023-12-30
Last updated
2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Management

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%.

Interventions

BEHAVIORALElastance Group

Fluids are given based on dynamic elastane value

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

patients enrolled for major abdominal surgery \-

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
lactate levelsat the end of surgery

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026