NCT02837731

Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Cheetah Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sepsis
• Hypotension

Interventions

Type	Name	Description
DEVICE	Treatment Starling SV monitor	A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.

Timeline

• Start date: 2016-10-01
• Primary completion: 2019-03-01
• Completion: 2019-03-13
• First posted: 2016-07-20
• Last updated: 2020-12-03
• Results posted: 2020-12-03

Locations

12 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study