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Completed

NCT Number: NCT04332861

Evaluation of Infection in Obstructing Urolithiasis

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Initial clinical and laboratory evaluation

Other

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

Acronym: eIOU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 3, 2020
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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