Early Goal Directed Therapy in Sepsis by Emergency Medical Services

Sepsis Clinical Trial

Official title:

Early Goal Directed Therapy in Sepsis by EMS

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02266654
• Other study ID #: 019-2014
• Status: Withdrawn
• Phase: N/A
• First received: June 9, 2014
• Last updated: April 13, 2017
• Start date: October 2014
• Est. completion date: May 2017

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• IV fluids
Normal Saline 0.9%
• Hospital Notification
Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria

Locations

Country	Name	City	State
United States	Mount Auburn Hospital	Cambridge	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Mount Auburn Hospital, Pro EMS

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to antibiotics		During the Emergency Department stay (expected to be 5 hours)
Secondary	Mortality		Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Need for pressors in the Emergency Department		During the Emergency Department stay (expected to be 5 hours)
Secondary	Admitted to the Intensive Care Unit from the Emergency Department		During the Emergency Department stay (expected to be 5 hours)