Early Goal Directed Therapy in Sepsis by Emergency Medical Services

NCT02266654 | Withdrawn

• 1 other identifier: 019-2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Emergency Medical Services; Lactic Acid; Sepsis

Outcome Measures

Primary Outcomes (1)

• Time to antibiotics

  During the Emergency Department stay (expected to be 5 hours)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Prehospital-directed therapy arm

EXPERIMENTAL

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; Other: Hospital Notification

Control Arm

EXPERIMENTAL

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

Other: IV fluids

Interventions

IV fluids OTHER

Normal Saline 0.9%

Control Arm; Prehospital-directed therapy arm

Hospital Notification OTHER

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

Prehospital-directed therapy arm

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Transfer from another hospital
• Patients, coming from a rehabilitation/nursing facility where antibiotics were given prior to transfer
• Pregnant patients
• Prisoners.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pro EMS: collaborator
• Mount Auburn Hospital: collaborator

Study Sites (1)

Mount Auburn Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Sepsis

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Michael Filbin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• William Porcaro, MD, MPH

  Mount Auburn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: October 17, 2014
• Study Start: October 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 17, 2017

Record last verified: 2017-04

Locations

US (1)