Sepsis
Conditions
Brief summary
The primary objective of this study is to test whether a fluid resuscitation protocol guided by non-invasive hemodynamic measures reduces the progression of organ dysfunction (defined by an increase in the Serial Organ Failure Assessment Score ≥ 1 over the first 72 hours) in sepsis patients presenting to the Emergency Department without evidence of shock.
Interventions
OTHERFluid Resuscitation
In the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is fluid responsive (FR).
OTHERStandard of Care
Standard of Care
Sponsors
Cheetah Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients \> 18 years with old suspected or confirmed infection 2. At least two of the following four criteria (SIRS): 1. Temperature \> 38 or \< 36o C 2. Heart rate \> 90 bpm 3. Respiratory rate \> 20 bpm or PaCO2\< 32 mmHg 4. White blood cell count \>12,000 or \<4,000 per mm3; or \>10% bandemia 3. Lactate ≥2.0 and ≤4.0 mMol/L 4. Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
Exclusion criteria
1. Age \< 18 years 2. On vasopressor therapy 3. Systolic blood pressure \< 90 mmHg 4. Received more than 3-liter crystalloid fluid prior to randomization 5. Patient presenting with pulmonary edema 6. Patient presenting with acute coronary syndrome 7. Patient presenting with new onset cardiac arrhythmia 8. Patient presenting with trauma, including burns 9. Patient requires immediate surgery 10. Patient presenting with stroke 11. Patient with end stage renal disease on renal replacement therapy 12. Patient with known pregnancy 13. Patient being treated with immunosuppressive therapy for organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment. | 72 hours | A patient will be considered to have progressive organ dysfunction if their Sequential Organ Failure Assessment (SOFA) score increases by ≥1 point from their baseline score within 72 hours of study enrollment. |
Countries
United States
Outcome results
None listed