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Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis

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ClinicalTrials.gov Identifier: NCT04667195
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
University of Southern Denmark

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.

Condition or disease Intervention/treatment
Acute Pyelonephritis 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis in the Emergency Department: A Cross-sectional Study
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Verified and non verified APN [ 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.


Secondary Outcome Measures :
  1. Intensive care treatment [ 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)

  2. Length of hospital stay [ Time Frame: within 60 days from current admission to the emergency department ]
    days spent in hospital during current admission

  3. 30-days mortality [ Time Frame: within 30 days from arrival day ]
    binary

  4. Readmission [ 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

  5. In-hospital mortality [ Time Frame: within 60 days from current admission to the emergency department ]
    binary


Other Outcome Measures:
  1. 90-days mortality [ Time Frame: within 90 days from day of admission ]
    binary

  2. Level of infection markers [ Time Frame: within 4 hours from admission ]
    Concentration of serum procalcitonin, CRP and suPAR

  3. Urological intervention [ Time Frame: within 60 days from current admission to the emergency department ]
    Binary

  4. Bacteriuria [ Time Frame: within 4 hours from admission ]
    Binary outcome defined by microbiologist on urine culture analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04667195


Contacts
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Contact: Anne Heltborg, MD +45 27632315 Anne.Heltborg.Kristensen@rsyd.dk
Contact: Helene Skoet-Arkil +45 41219657 Helene.Skjoet-Arkil@rsyd.dk

Locations
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Denmark
Hospital of Southern Jutland Recruiting
Aabenraa, Denmark
Contact: Christian B Mogensen, MD         
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Study Chair: Christian Backer Mogensen Institute for Regional Health Research
Publications:
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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04667195    
Other Study ID Numbers: SHS-ED-12a-2020
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
symptoms
Acute Pyelonephritis
clinical characteristics
upper urinary tract infection
Emergency department
Additional relevant MeSH terms:
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Pyelonephritis
Nephritis, Interstitial
Nephritis
Kidney Diseases
Urologic Diseases
Pyelitis