Hospital of Southern Jutland
Aabenraa, Denmark
NCT Number: NCT04667195
Acute pyelonephritis is an acute infection. Today the diagnosis is made primarily on the basis of unspecific clinical symptoms with flank tenderness combined with as a key clue. This study will investigate which clinical and paraclinical characteristics available within 4 hours of hospital stay, that describes the patients admitted in the emergency department with acute pyelonephritis the best.
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Notify Me18 year and older
All sexes
Observational
Aabenraa, Denmark
Acute pyelonephritis (APN) is a severe acute infection in the upper urinary tract, which quite frequently is seen in the emergency department (ED). In our study, we define APN as a urinary tract infection with extension above the bladder, implicated by systemic affection in a suspected urinary tract infection (ie, fever, chills, malaise and/or lethargy beyond normal, signs of sepsis). Most often, an infection of the bladder ascends to the kidneys, causing APN. Symptoms and clinical affection range from mild to severe, but it is always important to recognize and treat APN fast in order to prevent progression to sepsis, renal failure and ultimately death.
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Within 4 hours of admission to the emergency department, clinical assessment will include:
Time frame: 2 months after patient discharge
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.
Time frame: within 60 days from admission to the emergency department
Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)
Time frame: within 60 days from current admission to the emergency department
days spent in hospital during current admission
Time frame: within 30 days from arrival day
binary
Time frame: 30 days from day of discharge
If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome
Time frame: within 60 days from current admission to the emergency department
binary
Time frame: within 90 days from day of admission
binary
Time frame: within 4 hours from admission
Concentration of serum procalcitonin, CRP and suPAR
Time frame: within 60 days from current admission to the emergency department
Binary
Time frame: within 4 hours from admission
Binary outcome defined by microbiologist on urine culture analysis
University of Southern Denmark
Other
Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis in the Emergency Department: A Cross-sectional Study
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