Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

Evaluation of Infection in Obstructing Urolithiasis

Sponsors

Lead sponsor: University of Texas Southwestern Medical Center

Source 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.

Overall Status Enrolling by invitation
Start Date September 3, 2019
Completion Date May 2020
Primary Completion Date May 2020
Study Type Observational
Primary Outcome
Measure Time Frame
Urinary tract infection (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 On average within 24-72 hours after initial clinical and laboratory evaluation
Secondary Outcome
Measure Time Frame
Bacteremia (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 On average within 24-72 hours after initial clinical and laboratory evaluation
Enrollment 450
Condition
Intervention

Intervention type: Other

Intervention name: Initial clinical and laboratory evaluation

Description: 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

Arm group label: Prospective observational cohort

Eligibility

Sampling method: Probability Sample

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Overall Official
Location
facility
Parkland Memorial Hospital | Dallas, Texas, 75235, United States
UT Southwestern Medical Center Clements University Hospital | Dallas, Texas, 75235, United States
Location Countries

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Prospective observational cohort

Description: 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

Acronym eIOU
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov