Early Goal Directed Therapy in Sepsis by Emergency Medical Services

NCT ID: NCT02266654

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-05-31

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.

Conditions

Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IV fluids

Intervention Type: OTHER

Normal Saline 0.9%

Hospital Notification

Intervention Type: OTHER

Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria

Control Arm

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

Group Type: EXPERIMENTAL

IV fluids

Intervention Type: OTHER

Normal Saline 0.9%

Interventions

IV fluids

Normal Saline 0.9%

Intervention Type: 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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pro EMS

UNKNOWN

Sponsor Role: collaborator

Mount Auburn Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Michael Filbin, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Filbin, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

William Porcaro, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mount Auburn Hospital

Locations

Mount Auburn Hospital

Cambridge, Massachusetts, United States

Countries

United States

Other Identifiers

019-2014

Identifier Type: -

Identifier Source: org_study_id