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Fluid Responsiveness Evaluation in Sepsis-associated Hypotension — FRESH  

Sepsis Clinical Trial

Official title:
Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension

Clinical Trial Summary

This study assesses the mean difference in fluid balance at ICU discharge and associated patient outcomes, based on a dynamic assessment of fluid responsiveness in septic patients with refractory hypotension in an ICU setting.

Clinical Trial Description

Multi-center randomized study comparing dynamic assessment of fluid responsiveness utilizing Starling SV monitor compared to a control group. Subjects will be randomized in a 2:1 treatment to control group ratio to increase power for sub-analysis by patient population. Patients randomized to the Starling SV arm will have treatment guided by a dynamic assessment of fluid responsiveness (measured by a change in stroke volume index > 10%) as assessed by passive leg raise (PLR). Patients randomized to the control group will receive standard of care treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02837731
Study type Interventional
Source Baxter Healthcare Corporation
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date March 13, 2019
View Details
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