Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Not Applicable

Withdrawn

• Conditions: Sepsis
• Interventions: Other: IV fluids; Other: Hospital Notification

• Registration Number: NCT02266654
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-09
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-13
• Last Update Posted: 2017-04-17
• Primary Completion: 2017-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehospital-directed therapy arm	IV fluids	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.
Control Arm	IV fluids	Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary.
Prehospital-directed therapy arm	Hospital Notification	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.

Primary Outcome Measures

Name	Time	Method
Time to antibiotics	During the Emergency Department stay (expected to be 5 hours)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mount Auburn Hospital; 🇺🇸 Cambridge, Massachusetts, United States