Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-02 @ 5:11 AM
Study NCT ID:
NCT04667195
Status:
COMPLETED
Last Update Posted:
2022-09-14
First Post:
2020-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 966}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-13', 'studyFirstSubmitDate': '2020-12-08', 'studyFirstSubmitQcDate': '2020-12-08', 'lastUpdatePostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '90-days mortality', 'timeFrame': 'within 90 days from day of admission', 'description': 'binary'}, {'measure': 'Level of infection markers', 'timeFrame': 'within 4 hours from admission', 'description': 'Concentration of serum procalcitonin, CRP and suPAR'}, {'measure': 'Urological intervention', 'timeFrame': 'within 60 days from current admission to the emergency department', 'description': 'Binary'}, {'measure': 'Bacteriuria', 'timeFrame': 'within 4 hours from admission', 'description': 'Binary outcome defined by microbiologist on urine culture analysis'}], 'primaryOutcomes': [{'measure': 'Verified and non verified APN', 'timeFrame': '2 months after patient discharge', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Intensive care treatment', 'timeFrame': 'within 60 days from admission to the emergency department', 'description': 'Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'within 60 days from current admission to the emergency department', 'description': 'days spent in hospital during current admission'}, {'measure': '30-days mortality', 'timeFrame': 'within 30 days from arrival day', 'description': 'binary'}, {'measure': 'Readmission', 'timeFrame': '30 days from day of discharge', 'description': 'If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome'}, {'measure': 'In-hospital mortality', 'timeFrame': 'within 60 days from current admission to the emergency department', 'description': 'binary'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['symptoms', 'Acute Pyelonephritis', 'clinical characteristics', 'upper urinary tract infection', 'Emergency department'], 'conditions': ['Acute Pyelonephritis']}, 'referencesModule': {'references': [{'pmid': '29298155', 'type': 'BACKGROUND', '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.'}, {'pmid': '15768623', 'type': 'BACKGROUND', 'citation': 'Ramakrishnan K, Scheid DC. Diagnosis and management of acute pyelonephritis in adults. Am Fam Physician. 2005 Mar 1;71(5):933-42.'}, {'pmid': '39638587', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34593497', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.\n\nIn 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:\n\n* To identify clinical and paraclinical relevant information available within 4 hours of admission that are associated with APN patients\n* To investigate the association between adverse events and clinical and paraclinical relevant information in patients with APN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acutely admitted patients with suspected APN from three emergency departments in the Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebælt, Odense University Hospital)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Suspicion of APN assessed by the receiving physician.\n\nExclusion Criteria:\n\n* If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.\n* Admission within the last 14 days\n* Verified COVID-19 disease within 14 days before admission\n* Pregnant women\n* 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)'}, 'identificationModule': {'nctId': 'NCT04667195', 'briefTitle': 'Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis in the Emergency Department: A Cross-sectional Study', 'orgStudyIdInfo': {'id': 'SHS-ED-12a-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected acute pyelonephritis', 'description': 'Diagnosis of APN suspected at the initial clinical assessment by the receiving emergency department physician', 'interventionNames': ['Other: Clinical assessment']}], 'interventions': [{'name': 'Clinical assessment', 'type': 'OTHER', 'description': 'Within 4 hours of admission to the emergency department, clinical assessment will include:\n\n* Demographics,\n* comorbidity,\n* symptoms,\n* objective findings,\n* triage at admission,\n* blood test results,\n* urine test results', 'armGroupLabels': ['Suspected acute pyelonephritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aabenraa', 'country': 'Denmark', 'facility': 'Hospital of Southern Jutland', 'geoPoint': {'lat': 55.04434, 'lon': 9.41741}}], 'overallOfficials': [{'name': 'Christian Backer Mogensen', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute for Regional Health Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}