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| Name | Class |
|---|---|
| Therapeutic Monitoring Systems | OTHER |
| MaRS Discovery District | OTHER |
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The overall objective of this study is to utilize heart rate variability and respiratory rate variability in patients with sepsis to predict clinical deterioration and death.
Our specific objectives are:
B. Hypotheses H1: In the initial resuscitation of sepsis, a low or declining multi-parameter composite variability index (CVI) over 4 hours will predict a significant increase in the combined outcome of overt shock, organ dysfunction, and mortality.
H2: In the initial resuscitation of sepsis, low volume fluid resuscitation (<20 cc/kg) over 4 hours will be associated with a low or declining CVI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ED patients with suspected infection |
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| Measure | Description | Time Frame |
|---|---|---|
| Progressive organ failure | A. SOFA score increase by ≥ 1 from baseline B. Overt shock C. Mortality (all-cause, in-hospital) | 72 hours |
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Inclusion Criteria:
1. Antibiotics ordered or administered (as surrogate for suspected or confirmed infection as primary reason for hospital admission as determined by the primary team) 2. Serum lactate ≥ 2.0 mmol/L or transient hypotension (any systolic blood pressure < 100 mmHg).
3. Identification within 12 hours of a qualifying lactate measurement or hypotension episode 4. Hospital admission planned for suspected infection as primary reasons for admission (per emergency medicine team).
Exclusion Criteria:
1. Age < 18 years 2. Pregnancy 3. Non-sinus cardiac rhythm (atrial fibrillation, active pacemaker, SVT) 4. Evidence of Overt Shock upon enrollment:
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Patients admitted through the ED for suspected infection as primary reason for admission.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Arnold, MD | Christiana Care Health Services | Principal Investigator |
| Andrew JE Seely, MD, PhD | Ottawa Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health Medical Center | Denver | Colorado | 80204 | United States | ||
| Christiana Health System |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012769 | Shock |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Newark |
| Delaware |
| 19718 |
| United States |
| Billings Clinic | Billings | Montana | 59101 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |