Evaluation of Infection in Obstructing Urolithiasis

Study Overview
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Brief Summary
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Obstructing urolithiasis can be life-threatening in the setting of urinary tract infection. The purpose of this study is to identify and validate risk factors and markers for the presence of infection and development of sepsis among patients with obstructing urolithiasis.

Detailed Description
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An obstructing stone and suspected urinary tract infection is an indication for drainage of the renal collecting system. In this setting, decompression with a ureteral stent or percutaneous nephrostomy (PCN) is associated with decreased mortality and both methods have similar efficacy. At the time of initial evaluation, it is sometimes uncertain whether infection is present, resulting in difficult management decisions. It is also difficult to identify infected patients at greatest risk of developing sepsis, defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. There are currently no widely adopted criteria for the accurate diagnosis of infection in the setting of an obstructing stone. Abnormal vital signs, leukocytosis, and abnormal urinalysis are relied upon, but these findings are often indeterminate. Most studies to date addressing this problem have retrospectively evaluated associations of single variables with infection including pyuria and bacteriuria, or performance of sepsis screening tools such as the Sepsis-related Organ Failure Assessment (SOFA). More accurate diagnostic measures for infected obstructing urolithiasis and a better understanding of its natural history are needed in order to improve patient outcomes. While early recognition of patients at significant risk of developing sepsis is essential, treatment of patients who are not clinically infected with antibiotics and decompression procedures is unnecessarily morbid. Therefore, the investigators aim to develop and validate diagnostic criteria to predict development of life-threatening infection in a prospective observational fashion.

Official Title
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Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

Conditions
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Sepsis, Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection

Intervention / Treatment
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* Other: Initial clinical and laboratory evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 18 and older Acute presentation of obstructing urolithiasis diagnosed on CT Exclusion Criteria: Indwelling nephrostomy tubes or ureteral stents Staghorn calculi or evidence of xanthogranulomatous pyelonephritis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective observational cohort<br>For data analysis, the cohort will be subdivided as follows: Identification and Validation cohorts Patients with and without complicating factors Patients with and without measured inflammatory marker levels | Other: Initial clinical and laboratory evaluation<br>* Initial evaluation, prior to administration of any antibiotics if possible, includes history, physical exam, and labs including: Urinalysis Urine culture Blood cultures Complete blood count with differential Comprehensive metabolic panel Lactate Procalcitonin Other inflammatory markers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary tract infection (positive urine culture) | Urinary tract infection, defined as a positive urine culture | Within 24-72 hours of initial clinical and laboratory evaluation | 
| Intensive care unit admission and/or death due to sepsis during inpatient encounter | Intensive care unit admission and/or death secondary to sepsis, occurring during the inpatient incounter. | On average within 24-72 hours after initial clinical and laboratory evaluation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteremia (at least one positive blood culture) | Bacteremia, defined as at least one positive blood culture | Within 24-72 hours of initial clinical and laboratory evaluation | 
| Pyonephrosis (drainage of pus from the involved kidney) during inpatient encounter | Pyonephrosis, defined as drainage of pus from the involved kidney at any point during the inpatient encounter | On average within 24-72 hours after initial clinical and laboratory evaluation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection, Sepsis