Clinical Trials Logo
  1. Home
  2. Fluid Management
  3. NCT05187273
  4. Details
NCT05187273 Clinical Trial

Hemodynamic Optimization Based on a Dynamic Elastance Protocol

Fluid Management Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05187273
Other study ID # ID3724
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 25, 2021
Est. completion date December 30, 2023

Study information
Verified date March 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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%.

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date December 30, 2023
Est. primary completion date August 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Elastance Group
Fluids are given based on dynamic elastane value

Locations
Country Name City State
Italy Andrea Russo Rome

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary lactate levels at the end of surgery
See also
  Status Clinical Trial Phase
Terminated NCT03208023 - RESIPI for Reducing Perioperative Major Adverse Cardiac Events N/A
Completed NCT02271841 - How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.
Completed NCT00816153 - Pleth Variability Index and Fluid Management During Surgery N/A
Recruiting NCT04423224 - Non-invasive Stroke Volume-based fluid Management in Elderly Patients Undergoing Hip Fracture Surgery Under Spinal Anaesthesia N/A
Completed NCT04219150 - Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients N/A
Withdrawn NCT04265014 - Comparison of Goal-directed and Liberal Fluid Management N/A
Completed NCT01602978 - Comparison of Pulse Hemoglobin and Pleth Variability Index
Completed NCT05361252 - Stroke Volume Variation-guided Fluid Infusion in Major Liver Tumour Resection N/A