SepsisNCT05961137
Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures
A study testing Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol and Conventional Prehospital Suspected Sepsis Protocol in people with Sepsis and Emergency Medical Services, run by Orange Park Medical Center at 1 site in United States.
Trial summary
The goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Emergency Medical Services, Quality Improvement
- What is being tested?
- Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol and Conventional Prehospital Suspected Sepsis Protocol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting sepsis alert criteria who were transported to the study hospital's emergency department by one of the four rescue units involved in the study. Sepsis alert defined as patient has suspected infection and two or more of the following: (a) temperature > 38° C (100.4° F) or < 36° C (96.8° F), (b) respiratory rate > 20 breaths / minute or end-tidal carbon dioxide (ETCO2) ≤ 25 mmHg, or (c) heart rate > 90 beats / minute
Who cannot join
- prehospital trauma
- prehospital cardiac arrest prior to signaling sepsis alert
- interfacility transfer
- emergency transport from medical facility (e.g., medical office or clinic)
- intervention by medical practitioner before emergency medical services arrival
- do not resuscitate order in place
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange Park Medical Center
Orange Park, Florida, 32073
About this study
The goal of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval.
The main question[s] it aims to answer are:
- Does the intervention affect the timeliness of fluid administration?
- Does the intervention affect CMS sepsis bundle care measure compliance?
- Does the intervention affect processes and outcomes of care?
- Are there any adverse effects?
Researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.
- Being tested
- Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol, Conventional Prehospital Suspected Sepsis Protocol
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis ProtocolOther
Modified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.
Conventional Prehospital Suspected Sepsis ProtocolOther
Conventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids.
| Study group | Role | What they receive |
|---|---|---|
| After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol | Active comparator | Modified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. Receives: Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol |
| Before phase: Conventional Prehospital Suspected Sepsis Protocol | Active comparator | Conventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. Receives: Other: Conventional Prehospital Suspected Sepsis Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis
As defined according to the Centers for Medicare and Medicaid Services (CMS) Specifications Manual for Hospital Inpatient Quality Measures, version 5.9. "Time of presentation" or "time-zero" was defined as the time of triage in the Emergency Department. All patients enrolled in the study were assessed for measure compliance, without application of measure inclusion/exclusion criteria.
Measured: Assessed at 3 hours after ED arrival
Secondary outcomes (13)
Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour
Dichotomous measure of whether infusion volume was met, based on sum of prehospital and ED-based crystalloid fluid infusion
Measured: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused by time of ED arrival
Measured: During the 3 hours prior to ED arrival, while under care by EMS.
Total volume of intravenous crystalloid infused by 1 hour after ED arrival
Measured: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused by 3 hours after ED arrival
Measured: Assessed at 3 hours after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival
Measured: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival
Measured: Assessed at 3 hours after ED arrival
Percentage of study participants receiving any intensive care unit care
Measured: Through discharge from index acute-care episode, up to 6 months
Percentage of study participants with admission disposition during index ED visit
Measured: Through discharge from index acute-care episode, up to 6 months
Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival
Specified life-support interventions were mechanical ventilation, vasopressor use, cardiopulmonary resuscitation, surgical intervention.
Measured: Assessed at 24 hours after ED arrival
Percentage of enrollees experiencing in-hospital death
Measured: Through discharge from index acute-care episode, up to 6 months
Total length of stay in ED
Operationalized as time difference between ED clinician's documented disposition time and the patient's arrival time.
Measured: Through discharge from index acute-care episode, up to 6 months
Total length of stay in hospital
Among those admitted to the hospital as the disposition of their index ED visit.
Measured: Through discharge from index acute-care episode, up to 6 months
Total length of stay in intensive care unit
Measured: Through discharge from index acute-care episode, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Apr 2021
- Primary completion31 Dec 2021
- Study completion31 Aug 2022
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.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orange Park Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 410 Medical
- Responsible party
- Sponsor
- Investigators
- Martin P Wegman, MD, PhD, Principal investigator, Orange Park Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961137
- Sponsor's protocol ID
- 1-1260269-1
- Status last verified
- Jul 2023
- First submitted
- 22 May 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orange Park Out-of-Hospital Quality Improvement Study for Improving CMS Sepsis Core Measures
- ClinicalTrials.gov ID
- NCT05961137
- Acronym / sponsor ID
- 1-1260269-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Orange Park Medical CenterUniversity, hospital or other
- Collaborators
- 410 Medical
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 Jul 2023 (actual)
- 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 of this quality improvement study is to measure the impact of incorporation of a manual rapid fluid infuser (RFI) for intravenous crystalloid infusion in patients with suspected sepsis in the prehospital interval.
The main question[s] it aims to answer are:
- Does the intervention affect the timeliness of fluid administration?
- Does the intervention affect CMS sepsis bundle care measure compliance?
- Does the intervention affect processes and outcomes of care?
- Are there any adverse effects?
Researchers will compare this intervention to use of more conventional gravity or pressure-infusion bag crystalloid infusion.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group design with control group enrolled first, then a training period, then a separate intervention group enrolled.
| Arm | Type | Receives |
|---|---|---|
| After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol | Active comparator | Other: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis ProtocolModified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. |
| Before phase: Conventional Prehospital Suspected Sepsis Protocol | Active comparator | Other: Conventional Prehospital Suspected Sepsis ProtocolConventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients meeting sepsis alert criteria who were transported to the study hospital's emergency department by one of the four rescue units involved in the study. Sepsis alert defined as patient has suspected infection and two or more of the following: (a) temperature > 38° C (100.4° F) or < 36° C (96.8° F), (b) respiratory rate > 20 breaths / minute or end-tidal carbon dioxide (ETCO2) ≤ 25 mmHg, or (c) heart rate > 90 beats / minute
Key exclusion criteria (6 listed)
- prehospital trauma
- prehospital cardiac arrest prior to signaling sepsis alert
- interfacility transfer
- emergency transport from medical facility (e.g., medical office or clinic)
- intervention by medical practitioner before emergency medical services arrival
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 |
|---|---|---|
| Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis ProtocolModified protocol specifying intravenous crystalloid infusion Rapid Fluid Infusion Device. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. | Other | After-phase: Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol |
| Conventional Prehospital Suspected Sepsis ProtocolConventional protocol employing intravenous crystalloid infusion via gravity or pressurized-bag. The protocol states that for patients meeting the sepsis alert criterion, EMS will provide basic medical care, oxygen, a 12-lead electrocardiogram, attempt placement of an IV catheter and initiate administration of 30mL/kg of fluids. | Other | Before phase: Conventional Prehospital Suspected Sepsis Protocol |
Primary outcome
Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis
Time frame: Assessed at 3 hours after ED arrival
As defined according to the Centers for Medicare and Medicaid Services (CMS) Specifications Manual for Hospital Inpatient Quality Measures, version 5.9. "Time of presentation" or "time-zero" was defined as the time of triage in the Emergency Department. All patients enrolled in the study were assessed for measure compliance, without application of measure inclusion/exclusion criteria.
13 secondary outcomes
Percentage achievement of 30mL/kg crystalloid infusion for hypotension or lactate level > 4 mmol/L at 1 hour
Time frame: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused by time of ED arrival
Time frame: During the 3 hours prior to ED arrival, while under care by EMS.
Total volume of intravenous crystalloid infused by 1 hour after ED arrival
Time frame: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused by 3 hours after ED arrival
Time frame: Assessed at 3 hours after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 1 hour after ED arrival
Time frame: Assessed at 1 hour after ED arrival
Total volume of intravenous crystalloid infused, in the ED, by 3 hours after ED arrival
Time frame: Assessed at 3 hours after ED arrival
Percentage of study participants receiving any intensive care unit care
Time frame: Through discharge from index acute-care episode, up to 6 months
Percentage of study participants with admission disposition during index ED visit
Time frame: Through discharge from index acute-care episode, up to 6 months
Percentage of enrollees receiving any specified life-support interventions in the first 24 hours from ED arrival
Time frame: Assessed at 24 hours after ED arrival
Percentage of enrollees experiencing in-hospital death
Time frame: Through discharge from index acute-care episode, up to 6 months
Total length of stay in ED
Time frame: Through discharge from index acute-care episode, up to 6 months
Total length of stay in hospital
Time frame: Through discharge from index acute-care episode, up to 6 months
Total length of stay in intensive care unit
Time frame: Through discharge from index acute-care episode, up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Martin P Wegman, MD, PhD principal investigator
Orange Park Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incorporation of Rapid Fluid Infusion Device in Prehospital Suspected Sepsis Protocol and Conventional Prehospital Suspected Sepsis Protocol in people with Sepsis and Emergency Medical Services, run by Orange Park Medical Center 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jul 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage compliance with the CMS 3-hour sepsis bundle criterion (SEP-1) for patients with suspected sepsis (time frame: Assessed at 3 hours after ED arrival). 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 27 Jul 2023.