Evaluation of Infection in Obstructing Urolithiasis (eIOU)

December 12, 2023 updated by: Margaret Pearle, University of Texas Southwestern Medical Center

Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

477

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Memorial Hospital
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center Clements University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infection (positive urine culture)
Time Frame: Within 24-72 hours of initial clinical and laboratory evaluation
Urinary tract infection, defined as a 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
Time Frame: 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.
On average within 24-72 hours after initial clinical and laboratory evaluation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteremia (at least one positive blood culture)
Time Frame: Within 24-72 hours of initial clinical and laboratory evaluation
Bacteremia, defined as 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
Time Frame: 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
On average within 24-72 hours after initial clinical and laboratory evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2019

Primary Completion (Actual)

July 28, 2020

Study Completion (Actual)

July 28, 2020

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2018-0028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Initial clinical and laboratory evaluation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe