Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Study Overview
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Brief Summary
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The goal is to evaluate the best way for paramedics and hospitals to work together to treat septic patients as quickly as possible. The investigators think that the best thing to do for septic patients is to identify and treat them as early as possible. This research will test this. The investigators think that if paramedics identify septic patients and begin treatment with fluids in the ambulance, then the patient will do better in the long run. The paramedic will also tell the hospital that a septic patient will be there soon. The caregivers can prepare and be ready to provide care as soon as the patient arrives. With this research, the investigators would like to see if these steps help patient outcomes.

Official Title
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Early Goal Directed Therapy in Sepsis by EMS

Conditions
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Sepsis

Intervention / Treatment
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* Other: IV fluids
* Other: Hospital Notification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 17 years of age Suspected to having an infection Meets 2 of 3 systemic inflammatory response criteria: heart rate > 90 beats per minute, respiratory rate >20 breaths per minute, temperature >38°C or <36°C Exclusion Criteria: Transfer from another hospital Patients, coming from a rehabilitation/nursing facility where antibiotics were given prior to transfer Pregnant patients Prisoners.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehospital-directed therapy arm<br>Patients who are hypotensive or whose lactate is ≥ 2.5, prehospital providers will provide a notification to the receiving hospital (Hospital Notification), establish an IV, and provide 1 liter normal saline (NS) bolus of IV fluids. An additional 1 liter normal saline bolus will be given for systolic blood pressure less than 100. Patients who have a history of end-stage renal disease or congestive heart failure would receive only 20 milliliters/kilogram of fluid. If the patient remains hypotensive, Emergency Medical Services will continue providing fluids as is standard of care. | Other: IV fluids<br>* Normal Saline 0.9%<br>Other: Hospital Notification<br>* Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria<br>|
| Experimental: Control Arm<br>Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary. | Other: IV fluids<br>* Normal Saline 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to antibiotics |  | During the Emergency Department stay (expected to be 5 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | Participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| Need for pressors in the Emergency Department |  | During the Emergency Department stay (expected to be 5 hours) | 
| Admitted to the Intensive Care Unit from the Emergency Department |  | During the Emergency Department stay (expected to be 5 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emergency Medical Services, Lactic Acid, Sepsis