Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis

NCT ID: NCT04667195

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

966 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Acute Pyelonephritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Suspected acute pyelonephritis

Diagnosis of APN suspected at the initial clinical assessment by the receiving emergency department physician

Clinical assessment

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian Backer Mogensen

Role: STUDY_CHAIR

Institute for Regional Health Research

Locations

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Hospital of Southern Jutland

Aabenraa, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 29298155 (View on PubMed)

Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42.

Reference Type BACKGROUND
PMID: 15768623 (View on PubMed)

Skjot-Arkil H, Cartuliares MB, Heltborg A, Lorentzen MH, Hertz MA, Kaldan F, Specht JJ, Graumann O, Lindberg MJH, Mikkelsen PA, Nielsen SL, Jensen J, Roge BT, Rosenvinge FS, Mogensen CB. Clinical characteristics and diagnostic accuracy of preliminary diagnoses in adults with infections in Danish emergency departments: a multicentre combined cross-sectional and diagnostic study. BMJ Open. 2024 Dec 5;14(12):e090259. doi: 10.1136/bmjopen-2024-090259.

Reference Type DERIVED
PMID: 39638587 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34593497 (View on PubMed)

Other Identifiers

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SHS-ED-12a-2020

Identifier Type: -

Identifier Source: org_study_id

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