NCT04332861

Evaluation of Infection in Obstructing Urolithiasis

Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 477 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Kidney Stone
• Kidney Calculi
• Urinary Tract Obstruction
• Infection
• Sepsis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-09-03
• Primary completion: 2020-07-28
• Completion: 2020-07-28
• First posted: 2020-04-03
• Last updated: 2023-12-13

Locations

2 sites across 1 country: United States