Hemodynamic Optimization Based on a Dynamic Elastance Protocol

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%.

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Key information

Conditions

Fluid Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andrea Russo

Rome, 00166, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients enrolled for major abdominal surgery

Exclusion criteria

end-stage renal disease
severe heart dysfunction
heart rhythm alterations

Treatment and study plan

Elastance Group

Behavioral

Fluids are given based on dynamic elastane value

Primary outcomes

lactate levels

Time frame: at the end of surgery

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Jan 11, 2022
Registry last updated: Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed