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Predict Sepsis; the Predictive Value of Bedside Measures in the Ambulance

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ClinicalTrials.gov Identifier: NCT03249597
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Örebro University, Sweden
Information provided by (Responsible Party):
Lisa Kurland, Karolinska Institutet

Brief Summary:

Sepsis is a condition with a high mortality. Septic patients are frequently difficult to identify because of their non-specific presentations. There is also a low sensitivity of clinical judgment among health care personnel, and of existing screening tools, which are in turn typically based on vital parameters. Despite prior research, no unique sepsis biomarker has been identified so far.

There is a need for new strategies to identify sepsis which do not rely on vital parameters and traditional laboratory blood tests alone. The hypothesis of the investigators is that a combination of clinical variables measurable in the ambulance can be used to predict sepsis.

The aim of the current study is to determine the predictive value of keywords related to symptom presentation, vital parameters and point-of-care (POC) blood tests, alone and in combination, with respect to the outcome sepsis.

The study is performed in the Stockholm ambulance setting from April 2017. A total of 648 adult non-trauma patients will be included.


Condition or disease Intervention/treatment
Sepsis Sepsis Syndrome Sepsis, Severe Diagnostic Test: Blood test: Glukos, SuPAR, Laktat and HBP

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Study Type : Observational
Estimated Enrollment : 648 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predict Sepsis; the Predictive Value of Bedside Measures in the Ambulance
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
1. Suspected Infection.
Adult (≥18 years), non-trauma patient transported by the ambulance, who according to the EMS suffer from an infection.
Diagnostic Test: Blood test: Glukos, SuPAR, Laktat and HBP
Four blood tests described in the section "Biospecimen Description" are analyzed within the main study; Glukos, SuPAR, Laktat and HBP.

2. Control
Adult (>18 years of age), non-trauma patient immediately following the included patient with suspected infection, transported in the same ambulance but without infection.
Diagnostic Test: Blood test: Glukos, SuPAR, Laktat and HBP
Four blood tests described in the section "Biospecimen Description" are analyzed within the main study; Glukos, SuPAR, Laktat and HBP.




Primary Outcome Measures :
  1. Sepsis [ Time Frame: The first 30 hours from ED arrival. ]

    The primary outcome sepsis will be defined, in accordance to the sepsis-3-definition (13), as infection with organ dysfunction characterized by an increase of SOFA (Sequential Organ Failure Assessment) score of ≥2 points/ requirement of vasopressor treatment /increased lactate or presence of ≥2 quickSOFA (qSOFA) criteria: respiratory rate of 22/min or greater, altered mentation, or systolic blood pressure of 100 mm Hg or less.

    According to the sepsis-3-definition, serum lactate greater than 2 mmol/L (>18 mg/dL) is used.

    The sepsis diagnosis is based on an analysis of medical records from the receiving hospital for all patients having undergone the above described blood tests.



Secondary Outcome Measures :
  1. Severe sepsis in accordance to former definitions. [ Time Frame: Within 30 hours of ED arrival. ]
    Severe sepsis defined in accordance to the former criteria based on SIRS criteria (1,6) or infection in combination with organ dysfunction (1), and in accordance to the investigators´ previously developed severe sepsis criteria, adapted to emergency care (2).


Other Outcome Measures:
  1. Subgroup analyses [ Time Frame: During ambulance transport ]

    The distribution of keywords, the prevalence of abnormal vital parameters and the prevalence of increased levels of biomarkers in blood tests, in relation to gender, age categories, survivors versus deceased will be expressed in percentage of the total number of patients in the group.

    Unit of measure: percentage of the total number of patients in each group.


  2. In-hospital mortality [ Time Frame: Within the duration for the hospital stay, up to 12 weeks. ]
    In-hospital mortality is defined as in-hospital death in accordance with the in-hospital record system and will be expressed as percentage of the total number of patients in the group.


Biospecimen Retention:   Samples With DNA
A total of maximum 24 mL venous blood will be drawn from each included patient. P-(plasma) glucose (<1 ml, will be analyzed in the ambulance). An additional 5 tubes of venous blood will be taken: 1. P-lactate (Sodium fluoride tube, 4 ml), 2. P-SuPAR (EDTA tube, 4 ml), 3. P-HBP (EDTA tube, 6 ml- in the pilot study 4 ml), 4. EDTA tube 6 ml: whole blood for cytokines (caspase-1 generated interleukins: IL-1β, IL-18, IL-37), glucose metabolites and downstream regulators of immunometabolic processes (pyruvate, lactate, HIF, mTOR, etc) and 5. PAXgene tube 2,5 ml: whole blood for priming step of the inflammasome mRNA levels of pro-IL and NLRP3.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients for both cohorts will be selected among adult (≥18 years) non-trauma patients transported by the EMS, to any of the seven emergency hospitals of Stockholm.
Criteria

Inclusion Criteria:

  • Adult (≥18 years)
  • Non-trauma patients (patients fallen at home can be included)
  • Transported by ambulance to one of the seven emergency hospitals of Stockholm
  • Suspected infection (prehospital infection group) or the next consecutive patient cared for in the same ambulance, immediately following a patient suspected to have a infection but not him/ herself considered suffering from an infection (prehospital control group).

Exclusion Criteria:

-Patient/ relatives not speaking Swedish/English; i.e no possibility to obtain information regarding medical history.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249597


Contacts
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Contact: Ulrika M Wallgren, MD +46 (0)73-648 27 34 ulrika.wallgren@sll.se
Contact: Lisa Kurland, MD, PhD +46 (0)70-252 24 19 lisa.kurland@ki.se

Locations
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Sweden
AISAB (Ambulansen i Storstockholm AB) Not yet recruiting
Stockholm, Sweden
Contact: Åke Östman, CEO    +46 (0)70-484 30 71    ake.ostman@sll.se   
Falck ambulans AB Not yet recruiting
Stockholm, Sweden
Contact: Per Ryding, Director    +46 (0)73-373 29 49    Per.Ryding@se.Falck.com   
Samariten Ambulans AB Recruiting
Stockholm, Sweden
Contact: Ulf Kanfjäll, Manager    +46 (0)70-569 78 00    ulf.kanfjall@samariten.se   
Sponsors and Collaborators
Lisa Kurland
Örebro University, Sweden
Investigators
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Principal Investigator: Lisa Kurland, MD, PhD 1. Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Sjukhusbacken 10, SE 118 83 Stockholm, Sweden.
Publications:
Svenska Infektionsläkarföreningen . Vårdprogram för svår sepsis och septisk chock. 2013. http://infektion.net/sites/default/files/pdf/final_svar%20sepsis%20och%20septisk%20chock%20151103.pdf
Medical guidelines for the ambulance care. Stockholm City Council; 2015. http://www.aisab.nu/media/49863/2015_medicinska_behandlingsriktlinjer.pdf

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lisa Kurland, MD, PhD, Professor in Emergency Medicine, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03249597    
Other Study ID Numbers: 2016/2001-31/2
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lisa Kurland, Karolinska Institutet:
Sepsis
Emergency Medical Services
Prehospital
Emergency Care
Emergency Medicine
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock