An observational study in Kidney Stone, Kidney Calculi and Urinary Tract Obstruction, sponsored by University of Texas Southwestern Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by University of Texas Southwestern Medical Center · Observational
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.
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.
605 studies on the registry are indexed under Kidney Calculi; 164 are open to participants now.
This study's enrollment of 477 is above the median of 146 across 114 observational studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,009 studies on the registry; 201 are open to participants now.
Of its 138 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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Subjects will be men and women presenting to the emergency department or already admitted to the hospital with a new diagnosis of obstructing urolithiasis on computed tomography (CT).
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Exclusion Criteria:
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
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
Urinary tract infection (positive urine culture)
Urinary tract infection, defined as a positive urine culture
Time frame: 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.
Time frame: On average within 24-72 hours after initial clinical and laboratory evaluation
Bacteremia (at least one positive blood culture)
Bacteremia, defined as at least one positive blood culture
Time frame: 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
Time frame: On average within 24-72 hours after initial clinical and laboratory evaluation
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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