Accuracy of Infection Biomarkers in the Investigation of Patients With Suspected Acute Pyelonephritis

NCT04686318 | Completed

• 1 other identifier: SHS-ED-12c-2020
• Study Type: observational
• Target: 229
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the diagnostic and prognostic value of C-reactive protein (CRP), serum procalcitonin (PCT) and soluble urokinase plasminogen activator receptor (suPAR) in the initial investigation of patients hospitalized with suspected acute pyelonephritis (APN).

Conditions

Acute Pyelonephritis

Keywords

C-reactive protein; serum procalcitonin; soluble urokinase plasminogen activator receptor; diagnostic and prognostic markers; emergency department

Outcome Measures

Primary Outcomes (1)

• Verified and non verified acute pyelonephritis (APN)

  The decision of whether patients admitted with suspicion of APN actually has a final diagnosis of APN is based on a combination of all findings during admission. The verification of diagnosis requires human handling, interpretation and judgment. Therefore, in this study, an expert panel will define the reference standard for the diagnosis APN. The expert panel consists of two independent consultants from the emergency department with significant experience in emergency medicine and acute infections. They will individually determine whether or not the patient admitted suspected with APN actually had this diagnosis. The final diagnosis will be based on all available relevant information from the patient medical record including MRI of the kidneys. A standardized template will be used. Disagreement will be discussed until a consensus is reached.

  2 months after patient discharge

Secondary Outcomes (6)

• Intensive care unit treatment

  within 60 days from admission to the emergency department

• Length of stay

  within 60 days from current admission to the emergency department

• The number of participants who died within 30 days

  within 30 days from arrival day

• The number of participants who died within 90 days

  within 90 days from arrival to emergency department

• Readmission

  within 30 days from day of discharge

Other Outcomes (1)

• Bacteriuria

  urine collected within 4 hours of arrival to the emergency department

Study Arms (1)

suspected acute pyelonephritis

All patients admitted to the emergency department with suspected acute pyelonephritis assessed by the receiving physician

Diagnostic Test: Biomarkers for acute pyelonephritis

Interventions

Biomarkers for acute pyelonephritis DIAGNOSTIC_TEST

Blood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of CRP, PCT and suPAR. Laboratory staff will be blinded to participant diagnosis and outcome. CRP and PCT results will be available to the treating physician, but the suPAR result will not be available. * Diagnostic test of CRP. CRP will be measured using an immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi Cobas© systems. * Diagnostic test of PCT: Plasma PCT will be quantified by an automated sandwich immunoassay "ECLIA" (Elecsys®, BRAHMS PCT-analyses) on Cobas© within two hours from collection according to standard procedure. * Diagnostic test of suPAR: Plasma suPAR will be quantified by using the commercial available suPARnostic© Tubilatex assay reagents (ViroGates, Denmark) on Cobas© as previously validated (35). Separated plasma is kept refrigerated and analysed for suPAR within 48 hours after collection.

suspected acute pyelonephritis

Eligibility Criteria

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

Study Population

Acutely admitted patients with suspected Acute pyelonephritis (APN) from three emergency departments (EDs) in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)

You may qualify if:

• Suspicion of APN assessed by the receiving physician at the ED

You may not qualify if:

• If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
• Admission within the last 14 days
• Verified COVID-19 disease within 14 days before admission
• Pregnant women
• Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 \<200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (\>20 mg/day prednisone or equivalent for \>14 days within the last 30 days), Chemotherapy within 30 days)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (3)

• Hamie L, Daoud G, Nemer G, Nammour T, El Chediak A, Uthman IW, Kibbi AG, Eid A, Kurban M. SuPAR, an emerging biomarker in kidney and inflammatory diseases. Postgrad Med J. 2018 Sep;94(1115):517-524. doi: 10.1136/postgradmedj-2018-135839. Epub 2018 Sep 3.

  PMID: 30177549 BACKGROUND

• Schuetz P, Christ-Crain M, Muller B. Procalcitonin and other biomarkers to improve assessment and antibiotic stewardship in infections--hope for hype? Swiss Med Wkly. 2009 Jun 13;139(23-24):318-26. doi: 10.4414/smw.2009.12584.

  PMID: 19529989 BACKGROUND

• Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.

  PMID: 34593497 DERIVED

MeSH Terms

Conditions

Disease; Emergencies

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Christian Backer Mogensen

  Hospital of Southern Jutland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)