SepsisNCT02266654
Early Goal Directed Therapy in Sepsis by Emergency Medical Services
A study testing IV fluids and Hospital Notification in people with Sepsis, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- IV fluids and Hospital Notification
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Transfer from another hospital
- Patients, coming from a rehabilitation/nursing facility where antibiotics were given prior to transfer
- Pregnant patients
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Auburn Hospital
Cambridge, Massachusetts, 02138
About this study
Official title: 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.
- Conditions
- Sepsis
- Being tested
- IV fluids, Hospital Notification
- Keywords
- Emergency Medical Services, Lactic Acid, Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV fluidsOther
Normal Saline 0.9%
Hospital NotificationOther
Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: IV fluids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to antibiotics
Measured: During the Emergency Department stay (expected to be 5 hours)
Secondary outcomes (3)
Mortality
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Need for pressors in the Emergency Department
Measured: During the Emergency Department stay (expected to be 5 hours)
Admitted to the Intensive Care Unit from the Emergency Department
Measured: During the Emergency Department stay (expected to be 5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Why it stopped: Unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pro EMS, Mount Auburn Hospital
- Responsible party
- Principal investigator, Michael Filbin, MD, Massachusetts General Hospital
- Investigators
- Michael Filbin, MD, Principal investigator, Massachusetts General HospitalWilliam Porcaro, MD, MPH, Principal investigator, Mount Auburn Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266654
- Sponsor's protocol ID
- 019-2014
- Status last verified
- Apr 2017
- First submitted
- 9 Jun 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Goal Directed Therapy in Sepsis by EMS
- ClinicalTrials.gov ID
- NCT02266654
- Acronym / sponsor ID
- 019-2014
- Conditions
- Sepsis
- Keywords
- Emergency Medical Services, Lactic Acid, Sepsis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Pro EMS, Mount Auburn Hospital
- Study start
- Oct 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehospital-directed therapy arm | Experimental | Other: IV fluids, Other: Hospital NotificationPatients 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. |
| Control Arm | Experimental | Other: IV fluidsPrehospital providers will obtain a point of care lactate, establish an IV, and provide IV fluids as judged necessary. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Transfer from another hospital
- Patients, coming from a rehabilitation/nursing facility where antibiotics were given prior to transfer
- Pregnant patients
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV fluidsNormal Saline 0.9% | Other | Control Arm, Prehospital-directed therapy arm |
| Hospital NotificationPrehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria | Other | Prehospital-directed therapy arm |
Primary outcome
Time to antibiotics
Time frame: During the Emergency Department stay (expected to be 5 hours)
3 secondary outcomes
Mortality
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Need for pressors in the Emergency Department
Time frame: During the Emergency Department stay (expected to be 5 hours)
Admitted to the Intensive Care Unit from the Emergency Department
Time frame: During the Emergency Department stay (expected to be 5 hours)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Filbin, MD principal investigator
Massachusetts General Hospital
William Porcaro, MD, MPH principal investigator
Mount Auburn Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV fluids and Hospital Notification in people with Sepsis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to antibiotics (time frame: During the Emergency Department stay (expected to be 5 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.