Diagnostic Imaging of Acute Pyelonephritis

NCT04651244 | Completed

• 1 other identifier: SHS-ED-11a-2020
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Acute pyelonephritis is important to recognize and treat quickly. Today the diagnosis is primarily clinical and often challenging. Sometimes acute pyelonephritis is complicated by obstruction leading to hydronephrosis. The aim of this study is to investigate whether ultrasound scanning conducted by a radiologist can diagnose acute pyelonephritis. Also, the investigators will investigate whether health care professionals with basic ultrasound skills can diagnose hydronephrosis by point-of-care ultrasound scanning in patients suspected of acute pyelonephritis.

Conditions

Pyelonephritis Acute

Keywords

Complicated urinary tract infection; Hydronephrosis; Contrast enhanced Ultrasound; Ultrasound; Diagnostic imaging

Outcome Measures

Primary Outcomes (3)

• Comparison of inflammatory changes in the kidneys on CEUS compared to MRI

  Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion on CEUS, and edema or renal lesions on MRI. Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on CEUS compared to MRI. The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.

  Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison are conducted within 6 months after investigation.

• Comparison of inflammatory changes in the kidneys on gray scale US and spectral doppler compared to the reference standard MRI

  Findings on the investigations will be registered on predefined templates. Both kidneys will be described regarding signs of inflammation, where we e.g. look at perfusion and resistance on US, and edema or renal lesions on MRI. Results of the investigations on the same kidneys are compared in order to access specificity and sensitivity of findings on US compared to MRI. The conducting/describing radiologist will be informed of some standardized clinical and paraclinical parameters (e.g. fever, CRP, flank pain, relevant comorbidity), but will be blinded to the results of the other imaging investigations.

  Routine descriptions of the scans will be available within about 48 hours from recruitment. Focused descriptions and comparison is conducted within 6 after investigation.

• Sensitivity and specificity of point-of-care ultrasound on identifying hydronephrosis compared to MRI

  How many of hydronephroses in patients suspected of APN is discovered by point of care US performed by an investigator with basic point of care US skills? MRI of the kidneys conducted maximum 24 hours after the point of care US is used as reference standard.

  Within 48 hours

Secondary Outcomes (1)

• Proportion of patients with APN and hydronephrosis

  Within 12 month

Other Outcomes (1)

• Bacteriuria

  within 4 hours from admission

Study Arms (1)

Patients with suspected acute pyelonephritis

Patients admitted in the ED with suspected infection, where the initial medical assessment raises suspicion of APN.

Diagnostic Test: MRI; Diagnostic Test: Ultrasound performed by a radiologist; Diagnostic Test: Point of care ultrasound

Interventions

MRI DIAGNOSTIC_TEST

Gold standard for identifying inflammatory changes in patients with acute pyelonephritis

Patients with suspected acute pyelonephritis

Ultrasound performed by a radiologist DIAGNOSTIC_TEST

US performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS).

Patients with suspected acute pyelonephritis

Point of care ultrasound DIAGNOSTIC_TEST

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.

Patients with 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

Participants will be included among patients admitted at the ED of three Danish hospitals in the Region of Southern Denmark: the ED in Kolding, Lillebælt Hospital, the ED in Aabenraa, Hospital Sønderjylland, and the ED in Odense, Odense University Hospital. A Danish ED corresponds to an acute medical ward. Either a general practitioner or a prehospital emergency medical service refers patients visiting a Danish ED, or patients get admitted because they called the emergency centre telephone number (1-1-2).

You may qualify if:

• Suspicion of acute pyelonephritis by ED physician
• Suspicion of urinary tract infection by ED physician and systemic affection (e.g. fever, sepsis

You may not qualify if:

• Unable to undergo an MRI
• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (7)

• 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.

  PMID: 30834993 BACKGROUND

• 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.

  PMID: 24443116 BACKGROUND

• 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.

  PMID: 30466913 BACKGROUND

• 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.

  PMID: 30169495 BACKGROUND

• 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.

  PMID: 17941932 BACKGROUND

• 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.

  PMID: 28856401 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

Hydronephrosis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Christian Backer Mogensen

  Institute for Regional Health Research

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)