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Early Goal Directed Therapy in Sepsis by Emergency Medical Services
N/A
Waitlist Available
Led By Michael Filbin, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Sepsis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Prehospital-directed therapy armExperimental Treatment2 Interventions
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.
Group II: Control ArmExperimental Treatment1 Intervention
Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary.
Find a Location
Who is running the clinical trial?
Pro EMSUNKNOWN
Mount Auburn HospitalOTHER
4 Previous Clinical Trials
26,408 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,025 Previous Clinical Trials
13,413,868 Total Patients Enrolled
7 Trials studying Sepsis
5,775 Patients Enrolled for Sepsis
Michael Filbin, MDPrincipal InvestigatorMassachusetts General Hospital
William Porcaro, MD, MPHPrincipal InvestigatorMount Auburn Hospital