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:

1. 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

2. Refractory hypotension despite initial fluid resuscitation (1L of treatment fluid)

3. Patient enrolled in study as soon as possible (ideal window of 0-12 hours) and within
24 hours of arrival to the hospital

4. Anticipated ICU admission

5. Able to provide signed informed consent or consent can be obtained from the patient's
authorized representative

Exclusion Criteria:

1. 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

2. Known aortic insufficiency, or aortic abnormalities

3. Hemodynamic instability due to active gastrointestinal hemorrhage

4. Requires immediate surgery

5. Patient transferred to the ICU from another hospital unit

6. Do not attempt resuscitation (DNAR or DNR) order

7. Advanced directives restricting implementation of the resuscitation protocol

8. Contraindication to blood transfusion

9. Attending clinician deems aggressive resuscitation unsuitable

10. Transferred from another in-hospital setting

11. Not able to commence treatment protocol within 1 hour after randomization

12. Known intraventricular heart defect, such as ventral septal defect or atrial septal
defect

13. Use of additional hemodynamic monitoring involving stroke volume variation (SVV) to
determine fluid responsiveness

14. Seizure in the last 24 hours

15. Prisoner

16. Pregnancy

17. Age <18

18. Known allergy to sensor material or gel

19. Inability or contraindication to doing a passive leg raise with both extremities, such
as inability to interrupt venous compression boots

20. Suspected intra-abdominal hypertension

21. Inability to obtain IV access

22. Patient should be excluded based on the opinion of the Clinician/Investigator