NCT05187273CompletedNot Applicable
Intraoperative Fluid Optimization Based on a Dynamic Elastance Protocol During Major Abdominal Surgery: a Randomised Control Trial
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 sites in 1 country46 target enrollmentStarted: February 25, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46
- Locations
- 2
- Primary Endpoint
- lactate levels
Study Overview
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients enrolled for major abdominal surgery
Exclusion Criteria
- •end-stage renal disease
- •severe heart dysfunction
- •heart rhythm alterations
Outcomes
Primary Outcomes
lactate levels
Time Frame: at the end of surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
RUSSO ANDREA
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Sites (2)
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