Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Mass General Brigham

Status: Withdrawn

Conditions: Sepsis

Treatments: Other: Hospital Notification; Other: IV fluids

Study type: Interventional

Funder types: Other

Identifiers

NCT02266654

019-2014

Details and patient eligibility

About

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.

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Prehospital-directed therapy arm

Experimental group

Description:

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.

Treatment:

Other: Hospital Notification

Other: IV fluids

Control Arm

Experimental group

Description:

Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary.

Treatment:

Other: IV fluids