Clinical trial NCT04667195: Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis
Official title: Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis in the Emergency Department: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pyelonephritis
Keywords: symptoms
Acute Pyelonephritis
clinical characteristics
upper urinary tract infection
Emergency department
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Acutely admitted patients with suspected APN from three emergency departments in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)

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.

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)

Primary outcomes:
measure: Verified and non verified APN
timeFrame: 2 months after patient discharge
Secondary outcomes:
measure: Intensive care treatment
timeFrame: within 60 days from admission to the emergency department
measure: Length of hospital stay
timeFrame: within 60 days from current admission to the emergency department
measure: 30-days mortality
timeFrame: within 30 days from arrival day
measure: Readmission
timeFrame: 30 days from day of discharge
measure: In-hospital mortality
timeFrame: within 60 days from current admission to the emergency department
Other outcomes:
measure: 90-days mortality
timeFrame: within 90 days from day of admission
measure: Level of infection markers
timeFrame: within 4 hours from admission
measure: Urological intervention
timeFrame: within 60 days from current admission to the emergency department
measure: Bacteriuria
timeFrame: within 4 hours from admission
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
Study officials:
affiliation: Institute for Regional Health Research
name: Christian Backer Mogensen
role: STUDY_CHAIR
References:
citation: Johnson JR, Russo TA. Acute Pyelonephritis in Adults. N Engl J Med. 2018 Jan 4;378(1):48-59. doi: 10.1056/nejmcp1702758. No abstract available.
citation: Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42.
citation: 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.