Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis

Acute Pyelonephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667195
• Other study ID #: SHS-ED-12a-2020
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• 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.

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)

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Pyelonephritis

Intervention

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

Locations

Country	Name	City	State
Denmark	Hospital of Southern Jutland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Johnson JR, Russo TA. Acute Pyelonephritis in Adults. N Engl J Med. 2018 Jan 4;378(1):48-59. Review. Erratum in: N Engl J Med. 2018 Mar 15;378(11):1069. — View Citation

Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42. Review. Erratum in: Am Fam Physician. 2005 Dec 1;72(11):2182. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	90-days mortality	binary	within 90 days from day of admission
Other	Level of infection markers	Concentration of serum procalcitonin, CRP and suPAR	within 4 hours from admission
Other	Urological intervention	Binary	within 60 days from current admission to the emergency department
Other	Bacteriuria	Binary outcome defined by microbiologist on urine culture analysis	within 4 hours from admission
Primary	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	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
Secondary	Length of hospital stay	days spent in hospital during current admission	within 60 days from current admission to the emergency department
Secondary	30-days mortality	binary	within 30 days from arrival day
Secondary	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
Secondary	In-hospital mortality	binary	within 60 days from current admission to the emergency department