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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Patients will be randomized (1:1, stratified by site, in permutation blocks of 4) to the "Treatment" or "Standard Care" arms. |
|
| Control | Active Comparator | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluid Resuscitation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| sequential organ failure assessment score increases by greater or equal to 1 point from the baseline score within 72 hours of study enrollment. | 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. | 72 hours |
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Inclusion Criteria:
Adult patients > 18 years with old suspected or confirmed infection
At least two of the following four criteria (SIRS):
Lactate ≥2.0 and ≤4.0 mMol/L
Enrollment within 6 hours of ED presentation within 2.5 hours of meeting eligibility criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nate Shapiro, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| University of California |
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|
| Standard of Care | Other | Standard of Care |
|
| Sacramento |
| California |
| 95817 |
| United States |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States |
| Northwester University | Evanston | Illinois | 60208 | United States |
| MGH | Boston | Massachusetts | 02114 | United States |
| The Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dr. Nate Shapiro | Boston | Massachusetts | 02118 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| NY Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Humility of Mary Health Partners | Youngstown | Ohio | 98661 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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