Study Results
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Basic Information
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COMPLETED
19 participants
OBSERVATIONAL
2021-03-01
2022-06-01
Brief Summary
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Detailed Description
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Ultrasound (US) has a lot of advantages in an acute medical setting. It can be utilised at the bedside and is a gentle technique. Conventional grayscale US is not ideal when trying to identify APN. However, more specialized US techniques increase the diagnostic value of US. These techniques include the Doppler US and the contrast-enhanced US (CEUS). Studies suggest that CEUS can identify APN equally to contrast-enhanced CT. Therefore, US has the potential to become relevant in the investigation of patients with a suspected kidney infection in the ED.
This study aims to investigate whether additional diagnostic imaging, in particular US, of patients admitted to the ED with suspected APN will assist in a more reliable diagnosis. Furthermore, it will investigate if point-of-care US of the kidneys by an investigator with basic US skill can assist a more rapid recognition of hydronephrosis in APN patients with complicating obstruction.
The investigators will invite patients admitted with suspected APN to participate in this study, which will include three additional scans. The first is a point of care US of the kidneys by a study assistant to assess the presence or absence of hydronephrosis. The second is a US by a specialist from the Radiology Department using both Doppler US and CEUS. The third scan is a reference standard MRI of the kidneys at the Radiology Department. This will be performed at a similar time (or as close as possible) to the radiologist US. The MRI will be conducted on a 1,5 T MRI scanner and include the following sequences: planning, Dixon, T1 mapping, T2, T2 mapping, apparent diffusion coefficient (ADC) (100, 400, 800), MRI angio (3D VIBE), and Phase Contrast.
These additional imaging findings will be evaluated in relation to the clinical findings.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with suspected acute pyelonephritis
Patients admitted in the ED with suspected infection, where the initial medical assessment raises suspicion of APN.
MRI
Gold standard for identifying inflammatory changes in patients with acute pyelonephritis
Ultrasound performed by a radiologist
US performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS).
Point of care ultrasound
Point of care US by a study assistant with basic ultrasound skills and training to access the presence or absence of hydronephrosis. If hydronephrosis is present it will be graded into one of four categories.
Interventions
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MRI
Gold standard for identifying inflammatory changes in patients with acute pyelonephritis
Ultrasound performed by a radiologist
US performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS).
Point of care ultrasound
Point of care US by a study assistant with basic ultrasound skills and training to access the presence or absence of hydronephrosis. If hydronephrosis is present it will be graded into one of four categories.
Eligibility Criteria
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Inclusion Criteria
* Suspicion of urinary tract infection by ED physician and systemic affection (e.g. fever, sepsis
Exclusion Criteria
* Known allergy to US contrast
* 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)
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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Claeys KC, Blanco N, Morgan DJ, Leekha S, Sullivan KV. Advances and Challenges in the Diagnosis and Treatment of Urinary Tract Infections: the Need for Diagnostic Stewardship. Curr Infect Dis Rep. 2019 Mar 5;21(4):11. doi: 10.1007/s11908-019-0668-7.
Rathod SB, Kumbhar SS, Nanivadekar A, Aman K. Role of diffusion-weighted MRI in acute pyelonephritis: a prospective study. Acta Radiol. 2015 Feb;56(2):244-9. doi: 10.1177/0284185114520862. Epub 2014 Jan 17.
Cruz J, Figueiredo F, Matos AP, Duarte S, Guerra A, Ramalho M. Infectious and Inflammatory Diseases of the Urinary Tract: Role of MR Imaging. Magn Reson Imaging Clin N Am. 2019 Feb;27(1):59-75. doi: 10.1016/j.mric.2018.09.001. Epub 2018 Oct 29.
Quaia E, Correas JM, Mehta M, Murchison JT, Gennari AG, van Beek EJR. Gray Scale Ultrasound, Color Doppler Ultrasound, and Contrast-Enhanced Ultrasound in Renal Parenchymal Diseases. Ultrasound Q. 2018 Dec;34(4):250-267. doi: 10.1097/RUQ.0000000000000383.
Mitterberger M, Pinggera GM, Colleselli D, Bartsch G, Strasser H, Steppan I, Pallwein L, Friedrich A, Gradl J, Frauscher F. Acute pyelonephritis: comparison of diagnosis with computed tomography and contrast-enhanced ultrasonography. BJU Int. 2008 Feb;101(3):341-4. doi: 10.1111/j.1464-410X.2007.07280.x. Epub 2007 Oct 17.
Kazmierski B, Deurdulian C, Tchelepi H, Grant EG. Applications of contrast-enhanced ultrasound in the kidney. Abdom Radiol (NY). 2018 Apr;43(4):880-898. doi: 10.1007/s00261-017-1307-0.
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-11a-2020
Identifier Type: -
Identifier Source: org_study_id
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