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

NCT03249597 | Completed

• 1 other identifier: 2016/2001-31/2
• Study Type: observational
• Target: 956
• Locations: 1 country
• Sites: 1

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 956 adult non-trauma patients will be included.

Conditions

Sepsis; Sepsis Syndrome; Sepsis, Severe

Keywords

Sepsis; Emergency Medical Services; Prehospital; Emergency Care; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• Sepsis

  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.

  The first 36 hours from ED arrival.

Secondary Outcomes (1)

• Severe sepsis in accordance to former definitions.

  Within 36 hours of ED arrival.

Other Outcomes (2)

• Subgroup analyses

  During ambulance transport

• In-hospital mortality

  Within the duration for the hospital stay, up to 12 weeks.

Study Arms (2)

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

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

Interventions

Blood test: Glukos, SuPAR, Laktat and HBP DIAGNOSTIC_TEST

Four blood tests described in the section "Biospecimen Description" are analyzed within the main study; Glukos, SuPAR, Laktat and HBP.

1. Suspected Infection.; 2. Control

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Örebro University, Sweden: collaborator

Study Sites (1)

Samariten Ambulans AB

Stockholm, Sweden

Location

Related Publications (17)

• 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

  BACKGROUND

• Wallgren UM, Castren M, Svensson AE, Kurland L. Identification of adult septic patients in the prehospital setting: a comparison of two screening tools and clinical judgment. Eur J Emerg Med. 2014 Aug;21(4):260-5. doi: 10.1097/MEJ.0000000000000084.

  PMID: 24080997 BACKGROUND

• Wallgren UM, Antonsson VE, Castren MK, Kurland L. Longer time to antibiotics and higher mortality among septic patients with non-specific presentations--a cross sectional study of Emergency Department patients indicating that a screening tool may improve identification. Scand J Trauma Resusc Emerg Med. 2016 Jan 6;24:1. doi: 10.1186/s13049-015-0193-0.

  PMID: 26733395 BACKGROUND

• Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, Suppes R, Feinstein D, Zanotti S, Taiberg L, Gurka D, Kumar A, Cheang M. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med. 2006 Jun;34(6):1589-96. doi: 10.1097/01.CCM.0000217961.75225.E9.

  PMID: 16625125 BACKGROUND

• Studnek JR, Artho MR, Garner CL Jr, Jones AE. The impact of emergency medical services on the ED care of severe sepsis. Am J Emerg Med. 2012 Jan;30(1):51-6. doi: 10.1016/j.ajem.2010.09.015. Epub 2010 Oct 27.

  PMID: 21030181 BACKGROUND

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 BACKGROUND

• Kaukonen KM, Bailey M, Pilcher D, Cooper DJ, Bellomo R. Systemic inflammatory response syndrome criteria in defining severe sepsis. N Engl J Med. 2015 Apr 23;372(17):1629-38. doi: 10.1056/NEJMoa1415236. Epub 2015 Mar 17.

  PMID: 25776936 BACKGROUND

• Wallgren UM, Bohm KEM, Kurland L. Presentations of adult septic patients in the prehospital setting as recorded by emergency medical services: a mixed methods analysis. Scand J Trauma Resusc Emerg Med. 2017 Mar 3;25(1):23. doi: 10.1186/s13049-017-0367-z.

  PMID: 28253928 BACKGROUND

• Medical guidelines for the ambulance care. Stockholm City Council; 2015. http://www.aisab.nu/media/49863/2015_medicinska_behandlingsriktlinjer.pdf

  BACKGROUND

• Wenzel RP. Treating sepsis. N Engl J Med. 2002 Sep 26;347(13):966-7. doi: 10.1056/NEJMp020096. No abstract available.

  PMID: 12324551 BACKGROUND

• Koch A, Tacke F. Risk stratification and triage in the emergency department: has this become 'suPAR' easy? J Intern Med. 2012 Sep;272(3):243-6. doi: 10.1111/j.1365-2796.2012.02568.x. Epub 2012 Jul 29. No abstract available.

  PMID: 22759240 BACKGROUND

• Linder A, Christensson B, Herwald H, Bjorck L, Akesson P. Heparin-binding protein: an early marker of circulatory failure in sepsis. Clin Infect Dis. 2009 Oct 1;49(7):1044-50. doi: 10.1086/605563.

  PMID: 19725785 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Tuerxun K, Eklund D, Wallgren U, Dannenberg K, Repsilber D, Kruse R, Sarndahl E, Kurland L. Predicting sepsis using a combination of clinical information and molecular immune markers sampled in the ambulance. Sci Rep. 2023 Sep 10;13(1):14917. doi: 10.1038/s41598-023-42081-6.

  PMID: 37691028 DERIVED

• Wallgren UM, Jarnbert-Pettersson H, Sjolin J, Kurland L. Association between variables measured in the ambulance and in-hospital mortality among adult patients with and without infection: a prospective cohort study. BMC Emerg Med. 2022 Nov 23;22(1):185. doi: 10.1186/s12873-022-00746-x.

  PMID: 36418966 DERIVED

• Wallgren UM, Sjolin J, Jarnbert-Pettersson H, Kurland L. Performance of NEWS2, RETTS, clinical judgment and the Predict Sepsis screening tools with respect to identification of sepsis among ambulance patients with suspected infection: a prospective cohort study. Scand J Trauma Resusc Emerg Med. 2021 Sep 30;29(1):144. doi: 10.1186/s13049-021-00958-3.

  PMID: 34593001 DERIVED

• Wallgren UM, Sjolin J, Jarnbert-Pettersson H, Kurland L. The predictive value of variables measurable in the ambulance and the development of the Predict Sepsis screening tools: a prospective cohort study. Scand J Trauma Resusc Emerg Med. 2020 Jun 25;28(1):59. doi: 10.1186/s13049-020-00745-6.

  PMID: 32586337 DERIVED

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.

MeSH Terms

Conditions

Sepsis; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Lisa Kurland, MD, PhD

  Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor in Emergency Medicine

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: August 15, 2017
• Study Start: April 3, 2017
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)