Fluid Responsiveness Evaluation in Sepsis-associated Hypotension (FRESH)
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|ClinicalTrials.gov Identifier: NCT02837731|
Recruitment Status : Completed
First Posted : July 20, 2016
Results First Posted : December 3, 2020
Last Update Posted : December 3, 2020
|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)|
|Actual Enrollment :||150 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|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 13, 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 ]Fluid balance is defined as all intravenous fluids administered over a 72 hour period (or ICU discharge, whichever occurred first), minus all fluid output. Urine output was measured in the ICU in 12 hour increments.
- Percentage of Participants Requiring Renal Replacement Therapy [ Time Frame: Day 1 to Day 30 ]Renal replacement therapy (RRT) is therapy that replaces the normal blood-filtering function of the kidneys. It is used when the kidneys are not working well, which is called kidney failure and includes acute kidney injury and chronic kidney disease. Patient receives new treatment with dialysis.
- Percentage of Participants Requiring Ventilator Use [ Time Frame: Day 1 to Day 30 ]Patients did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.
- Length of ICU Stay [ Time Frame: Day 1 to Day 30 ]Intensive Car Unit (ICU) length of stay will be calculated using the earliest of date that the subject is medically ready for discharge when captured, the date of discharge, or the study exit date.
- Number of Hours of Ventilator Use [ Time Frame: Day 1 to Day 30 ]Patients that did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.Ventilator use might have improved (less use of ventilator support), had no change, or worsened (more use of ventilator support).
- Number of Hours of Vasopressor Use [ Time Frame: Day 1 to Day 30 ]Vasopressor drugs are provided to restore and maintain blood pressure in patients with septic shock. Patients that have vasopressors initiated throughout the trial are included in this analysis.
- Change From Baseline in Serum Creatinine Levels at 72 Hours [ Time Frame: Baseline, 72 hours ]The diagnosis of Acute Kidney Injury (AKI) is traditionally based on a rise in serum creatinine
- Volume of Fluid [ Time Frame: 72 hours ]Traditional methods of assessing fluid responsiveness (FR) such as vital signs, physical examination, and static measurements of circulatory pressure have shown not to reliably correlate with fluid responsiveness. In contrast, dynamic measurement of stroke volume (SV) following an intravenous (IV) fluid bolus or passive leg raise (PLR) is a safe and feasible method of rapidly assessing the effectiveness of fluid-induced augmentation of SV and cardiac output (CO). Mean volume of treatment fluid Administered (ml) at 72 hours or ICU discharge, whichever occurs first, between the two treatment groups
- Percentage of Participants With Major Adverse Cardiac Event (MACE) [ Time Frame: Day 1 to Day 30 ]Incidence of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.
- Number of Participants Experiencing an Adverse Event (AE) Related to Study Device [ Time Frame: Day 1 to Day 30 ]Adverse events associated with the treatment procedure.
- Percentage of Participants With Hospital Discharge Without ICU Readmission [ Time Frame: Day 1 to Day 30 ]
- Percentage of Participants Within Overall 30 Day Mortality Rate [ Time Frame: Day 1 to Day 30 ]Incidence of death.
- Number of Participants by Hospital Discharge Location [ Time Frame: Day 1 to Day 30 ]Patient location (either "home" or "other") following hospital discharge.
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
|United States, California|
|University of California San Francisco Medical Center|
|San Francisco, California, United States, 94143|
|United States, Colorado|
|Denver, Colorado, United States, 80204|
|United States, Georgia|
|Grady Memorial Hospital|
|Atlanta, Georgia, United States, 30303|
|United States, Indiana|
|Indiana University Methodist Hospital|
|Indianapolis, Indiana, United States, 46202|
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10016|
|New York Presbyterian Brooklyn Methodist Hospital|
|New York, New York, United States, 11215|
|United States, Ohio|
|Ohio State University Hospital|
|Columbus, Ohio, United States, 43210|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Royal Surrey County Hospital|
|Guildford, United Kingdom|