Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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: 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.

Official Title
-----------------
Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis in the Emergency Department: A Cross-sectional Study

Conditions
-----------------
Acute Pyelonephritis

Intervention / Treatment
-----------------
* Other: Clinical assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspicion of APN assessed by the receiving physician. 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected acute pyelonephritis<br>Diagnosis of APN suspected at the initial clinical assessment by the receiving emergency department physician | Other: Clinical assessment<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verified and non verified 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care treatment | Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred) | within 60 days from admission to the emergency department | 
| Length of hospital stay | days spent in hospital during current admission | within 60 days from current admission to the emergency department | 
| 30-days mortality | binary | within 30 days from arrival day | 
| Readmission | If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome | 30 days from day of discharge | 
| In-hospital mortality | binary | within 60 days from current admission to the emergency department | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
symptoms, Acute Pyelonephritis, clinical characteristics, upper urinary tract infection, Emergency department