Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis
NCT ID: NCT04667195
Last Updated: 2022-09-14
Study Results
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Basic Information
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COMPLETED
966 participants
OBSERVATIONAL
2021-03-01
2022-06-01
Brief Summary
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Detailed Description
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The diagnosis APN is primarily made clinically based on symptoms and supported by elevated biomarkers such as C-reactive protein (CRP) and leucocytes, and positive urinary test strips. The diagnostic process can be challenging as there is often weak and atypical symptoms.
The classic symptoms indicating APN is flank tenderness, fever and nausea/vomiting. Typical symptoms of cystitis (dysuria, pollakisuria, suprapubic pain, hematuria) are possible but often absent. Especially elderly can present with more generalized signs of infection with nothing clearly indicating localization to the urinary tract. A positive urine culture verifies the diagnosis, but it is only available after a minimum of 24 hours.
In this study, we seek to identify and quantify the patient characteristics available within 4 hours of hospital stay in patients with APN. The objectives are:
* To identify clinical and paraclinical relevant information available within 4 hours of admission that are associated with APN patients
* To investigate the association between adverse events and clinical and paraclinical relevant information in patients with APN.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Suspected acute pyelonephritis
Diagnosis of APN suspected at the initial clinical assessment by the receiving emergency department physician
Clinical assessment
Within 4 hours of admission to the emergency department, clinical assessment will include:
* Demographics,
* comorbidity,
* symptoms,
* objective findings,
* triage at admission,
* blood test results,
* urine test results
Interventions
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Clinical assessment
Within 4 hours of admission to the emergency department, clinical assessment will include:
* Demographics,
* comorbidity,
* symptoms,
* objective findings,
* triage at admission,
* blood test results,
* urine test results
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Christian Backer Mogensen
Role: STUDY_CHAIR
Institute for Regional Health Research
Locations
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Hospital of Southern Jutland
Aabenraa, , Denmark
Countries
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References
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Johnson JR, Russo TA. Acute Pyelonephritis in Adults. N Engl J Med. 2018 Jan 4;378(1):48-59. doi: 10.1056/nejmcp1702758. No abstract available.
Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42.
Skjot-Arkil H, Cartuliares MB, Heltborg A, Lorentzen MH, Hertz MA, Kaldan F, Specht JJ, Graumann O, Lindberg MJH, Mikkelsen PA, Nielsen SL, Jensen J, Roge BT, Rosenvinge FS, Mogensen CB. Clinical characteristics and diagnostic accuracy of preliminary diagnoses in adults with infections in Danish emergency departments: a multicentre combined cross-sectional and diagnostic study. BMJ Open. 2024 Dec 5;14(12):e090259. doi: 10.1136/bmjopen-2024-090259.
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.
Other Identifiers
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SHS-ED-12a-2020
Identifier Type: -
Identifier Source: org_study_id
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