Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (FRESH)
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|ClinicalTrials.gov Identifier: NCT02837731|
Recruitment Status : Recruiting
First Posted : July 20, 2016
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Hypotension||Device: Treatment Starling SV monitor||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Fluid Volume in Patients With Sepsis and Refractory Hypotension|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Treatment Starling SV monitor
A dynamic assessment of fluid responsiveness using the Starling SV monitor will be performed at every clinical decision point for the first 72 hours of study enrollment. Examples of a clinical decision point include a mean arterial pressure (MAP) of < 65, the decision to give additional fluid volume, and the decision to either escalate or wean vasopressors. Fluid responsiveness will be assessed using a passive leg raise (PLR) to guide corresponding treatment.
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.
No Intervention: Control
No required therapeutic protocol will be used for patient treatment, and is determined per the discretion of the physician and hospital standards.
- Fluid balance [ Time Frame: 72 hours ]Mean difference in fluid balance (L) at 72 hours or ICU discharge, whichever occurs first, between the two treatment groups
- Length of ICU stay [ Time Frame: 30 days ]Length of ICU stay (days) until subject is medically ready for discharge
- Number of hours free from ventilator [ Time Frame: 30 days ]Number of hours free from ventilator use (30 day period)
- Number of hours free from vasopressor use [ Time Frame: 30 days ]Number of hours free from vasopressor use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837731
|Contact: Jennifer Sahatjian, Psy.Demail@example.com|
|United States, Colorado|
|Denver, Colorado, United States, 80204|
|Contact: Terra Hiller, RN firstname.lastname@example.org|
|Principal Investigator: Ivor Douglas, MD|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Caryn Pope, RRT 713-873-2471 email@example.com|
|Principal Investigator: Philip Alapat, MD|