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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
University of California San Francisco Medical Center
San Francisco, California, United States
Denver Health
Denver, Colorado, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Fluid Balance
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.
Time frame: 72 hours
Percentage of Participants Requiring Renal Replacement Therapy
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.
Time frame: Day 1 to Day 30
Percentage of Participants Requiring Ventilator Use
Patients did not enter the study on ventilation, but required ventilator use during the study are included in the analysis.
Time frame: Day 1 to Day 30
Length of ICU Stay
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.
Time frame: Day 1 to Day 30
Number of Hours of Ventilator Use
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).
Time frame: Day 1 to Day 30
Number of Hours of Vasopressor Use
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.
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Indiana University Methodist Hospital
Indianapolis, Indiana, United States
NYU School of Medicine
New York, New York, United States
New York Presbyterian Brooklyn Methodist Hospital
New York, New York, United States
Ohio State University Hospital
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
...and 2 more locations
Time frame: Day 1 to Day 30
Change From Baseline in Serum Creatinine Levels at 72 Hours
The diagnosis of Acute Kidney Injury (AKI) is traditionally based on a rise in serum creatinine
Time frame: Baseline, 72 hours