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Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Primary Purpose

Sepsis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IV fluids
Hospital Notification
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Emergency Medical Services, Lactic Acid, Sepsis

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mount Auburn Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prehospital-directed therapy arm

Control Arm

Arm 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.

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

Outcomes

Primary Outcome Measures

Time to antibiotics

Secondary Outcome Measures

Mortality
Need for pressors in the Emergency Department
Admitted to the Intensive Care Unit from the Emergency Department

Full Information

First Posted
June 9, 2014
Last Updated
April 13, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Pro EMS, Mount Auburn Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02266654
Brief Title
Early Goal Directed Therapy in Sepsis by Emergency Medical Services
Official Title
Early Goal Directed Therapy in Sepsis by EMS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll participants
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Pro EMS, Mount Auburn Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Emergency Medical Services, Lactic Acid, Sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehospital-directed therapy arm
Arm Type
Experimental
Arm 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.
Arm Title
Control Arm
Arm Type
Experimental
Arm Description
Prehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary.
Intervention Type
Other
Intervention Name(s)
IV fluids
Intervention Description
Normal Saline 0.9%
Intervention Type
Other
Intervention Name(s)
Hospital Notification
Intervention Description
Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria
Primary Outcome Measure Information:
Title
Time to antibiotics
Time Frame
During the Emergency Department stay (expected to be 5 hours)
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Title
Need for pressors in the Emergency Department
Time Frame
During the Emergency Department stay (expected to be 5 hours)
Title
Admitted to the Intensive Care Unit from the Emergency Department
Time Frame
During the Emergency Department stay (expected to be 5 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Filbin, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Porcaro, MD, MPH
Organizational Affiliation
Mount Auburn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Auburn Hospital
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States

12. IPD Sharing Statement

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Early Goal Directed Therapy in Sepsis by Emergency Medical Services

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