Fluid Responsiveness Evaluation in Sepsis-associated Hypotension

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.

Inclusion criteria

• Diagnosis of sepsis, as exhibited by 2 or more of the following systemic inflammatory response syndrome (SIRS) criteria and a known or presumed infection at time of screening:

• Temperature of > 38 C or < 36 C
• Heart rate of > 90/min
• Respiratory rate of > 20/min or PaCO2 < 32 mm Hg (4.3 kPA)
• White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands
• Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)
• Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within 24 hours of arrival to the hospital
• Anticipated ICU admission
• Able to provide signed informed consent or consent can be obtained from the patient's authorized representative

Exclusion criteria

• Primary diagnosis of: acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, major cardiac arrhythmia, drug overdose, or injury from burn or trauma
• Known aortic insufficiency, or aortic abnormalities
• Hemodynamic instability due to active gastrointestinal hemorrhage
• Patient has received >3 liters of IV fluid prior to study randomization
• Requires immediate surgery
• Patient transferred to the ICU from another hospital unit
• Do not attempt resuscitation (DNAR or DNR) order
• Advanced directives restricting implementation of the resuscitation protocol
• Contraindication to blood transfusion
• Attending clinician deems aggressive resuscitation unsuitable
• Transferred from another in-hospital setting
• Not able to commence treatment protocol within 1 hour after randomization
• Known intraventricular heart defect, such as ventral septal defect or atrial septal defect
• Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to determine fluid responsiveness
• Seizure in the last 24 hours
• Prisoner
• Pregnancy
• Age <18
• Known allergy to sensor material or gel
• Inability or contraindication to doing a passive leg raise with both extremities, such as inability to interrupt venous compression boots
• Patient has an epidural catheter in place
• Suspected intra-abdominal hypertension
• Inability to obtain IV access
• Diabetic ketoacidosis
• Hyper-osmolarity syndrome
• Patient uncouples from treatment algorithm
• Patient should be excluded based on the opinion of the Clinician/Investigator