Evaluation of Infection in Obstructing Urolithiasis

Completed

• Conditions: Kidney Stone; Urinary Tract Obstruction; Kidney Calculi; Infection; Sepsis
• Interventions: Other: Initial clinical and laboratory evaluation

• Registration Number: NCT04332861
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Study Timeline

• Study Start: 2019-09-03
• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Primary Completion: 2020-07-28
• Study Completion: 2020-07-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

• Men and women 18 and older
• Acute presentation of obstructing urolithiasis diagnosed on CT

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Exclusion Criteria

• Indwelling nephrostomy tubes or ureteral stents
• Staghorn calculi or evidence of xanthogranulomatous pyelonephritis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective observational cohort	Initial clinical and laboratory evaluation	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center Clements University Hospital; 🇺🇸 Dallas, Texas, United States