Acute Pyelonephritis Clinical Trial
Official title:
What is the Diagnostic and Prognostic Accuracy of C-reactive Protein, Serum Procalcitonin and Soluble Urokinase Plasminogen Activator Receptor in the Initial Investigation of Patients With Suspected Acute Pyelonephritis
NCT number | NCT04686318 |
Other study ID # | SHS-ED-12c-2020 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2021 |
Est. completion date | June 1, 2022 |
Verified date | September 2022 |
Source | University of Southern Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 229 |
Est. completion date | June 1, 2022 |
Est. primary completion date | February 28, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Suspicion of APN assessed by the receiving physician at the ED Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital of Southern Jutland | Aabenraa |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark |
Denmark,
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. Review. — View Citation
Schuetz P, Christ-Crain M, Müller 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: smw-12584. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Bacteriuria | Binary outcome defined by microbiologist on urine culture analysis | urine collected within 4 hours of arrival to the emergency department | |
Primary | 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 | Intensive care unit treatment | transfer to ICU during current admission (binary outcome) | within 60 days from admission to the emergency department | |
Secondary | Length of stay | days spent in hospital during current admission | within 60 days from current admission to the emergency department | |
Secondary | The number of participants who died within 30 days | binary - 30-days mortality | within 30 days from arrival day | |
Secondary | The number of participants who died within 90 days | binary - 90 days mortality | within 90 days from arrival to emergency department | |
Secondary | Readmission | binary | within 30 days from day of discharge | |
Secondary | In-hospital mortality | binary | within 60 days from admission to the emergency department |
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