Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pyelonephritis
• Intervention / Treatment: Other: Clinical assessment

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.

• Study Type: Observational
• Enrollment (Actual): 966

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark
    • Hospital of Southern Jutland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected acute pyelonephritis; Diagnosis of APN suspected at the initial clinical assessment by the receiving emergency department physician	Other: Clinical assessment; 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacteriuria	Binary outcome defined by microbiologist on urine culture analysis	within 4 hours from admission
90-days mortality	binary	within 90 days from day of admission
Level of infection markers	Concentration of serum procalcitonin, CRP and suPAR	within 4 hours from admission
Urological intervention	Binary	within 60 days from current admission to the emergency department

Collaborators and Investigators

• Sponsor: University of Southern Denmark

Publications and helpful links

General Publications

• 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. Erratum In: N Engl J Med. 2018 Mar 15;378(11):1069.
• Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42. Erratum In: Am Fam Physician. 2005 Dec 1;72(11):2182.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2021
• Primary Completion (ACTUAL): February 28, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (ACTUAL): December 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: symptoms; Emergency department; clinical characteristics; Acute Pyelonephritis; upper urinary tract infection
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Nephritis, Interstitial; Pyelitis; Pyelonephritis
• Other Study ID Numbers: SHS-ED-12a-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No