eIOU: Evaluation of Infection in Obstructing Urolithiasis

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04332861

Collaborator

(none)

450

Enrollment

Locations

33.9

Anticipated Duration (Months)

225

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stone Kidney Calculi Urinary Tract Obstruction Infection Sepsis	Other: Initial clinical and laboratory evaluation

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 Design

Study Type:

Observational

Anticipated Enrollment :

450 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

Actual Study Start Date :

Sep 3, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Prospective observational cohort 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

Arm

Intervention/Treatment

Prospective observational cohort

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parkland Memorial Hospital	Dallas	Texas	United States	75235
2	UT Southwestern Medical Center Clements University Hospital	Dallas	Texas	United States	75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

Principal Investigator: Jodi Antonelli, MD, University of Texas Southwestern Medical Center
Principal Investigator: Margaret S Pearle, MD PhD, University of Texas Southwestern Medical Center