Hemodynamic Optimization Based on a Dynamic Elastance Protocol

Not Applicable

Completed

• Conditions: Fluid Management
• Interventions: Behavioral: Elastance Group

• Registration Number: NCT05187273
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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 available

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-12-25
• Study First Submitted QC: 2021-12-25
• Study First Posted: 2022-01-11
• Primary Completion: 2022-08-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-23
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

patients enrolled for major abdominal surgery

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
intervention	Elastance Group	-

Primary Outcome Measures

Name	Time	Method
lactate levels	at the end of surgery

Trial Locations

Locations (1)

Andrea Russo; 🇮🇹 Rome, Italy