Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Early Goal Directed Therapy in Sepsis by EMS

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis
• Intervention / Treatment: Other: IV fluids; Other: Hospital Notification

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Mount Auburn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prehospital-directed therapy arm; 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; Normal Saline 0.9%; Other: Hospital Notification; Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria
Experimental: Control Arm; Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary.	Other: IV fluids; Normal Saline 0.9%

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mount Auburn Hospital; Pro EMS
• Investigators: Principal Investigator: Michael Filbin, MD, Massachusetts General Hospital; Principal Investigator: William Porcaro, MD, MPH, Mount Auburn Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: June 9, 2014
• First Submitted That Met QC Criteria: October 13, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2017
• Last Update Submitted That Met QC Criteria: April 13, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Emergency Medical Services; Sepsis; Lactic Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 019-2014