Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
477 participants
OBSERVATIONAL
2019-09-03
2020-07-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Acute presentation of obstructing urolithiasis diagnosed on CT
Exclusion Criteria
* Staghorn calculi or evidence of xanthogranulomatous pyelonephritis
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Margaret Pearle
Professor of Medicine
Principal Investigators
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Jodi Antonelli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Margaret S Pearle, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern Medical Center Clements University Hospital
Dallas, Texas, United States
Countries
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References
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Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
Borofsky MS, Walter D, Shah O, Goldfarb DS, Mues AC, Makarov DV. Surgical decompression is associated with decreased mortality in patients with sepsis and ureteral calculi. J Urol. 2013 Mar;189(3):946-51. doi: 10.1016/j.juro.2012.09.088. Epub 2012 Sep 24.
Pearle MS, Pierce HL, Miller GL, Summa JA, Mutz JM, Petty BA, Roehrborn CG, Kryger JV, Nakada SY. Optimal method of urgent decompression of the collecting system for obstruction and infection due to ureteral calculi. J Urol. 1998 Oct;160(4):1260-4.
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Abrahamian FM, Krishnadasan A, Mower WR, Moran GJ, Talan DA. Association of pyuria and clinical characteristics with the presence of urinary tract infection among patients with acute nephrolithiasis. Ann Emerg Med. 2013 Nov;62(5):526-533. doi: 10.1016/j.annemergmed.2013.06.006. Epub 2013 Jul 11.
Cheung F, Loeb CA, Croglio MP, Waltzer WC, Weissbart SJ. Bacteria on Urine Microscopy Is Not Associated with Systemic Infection in Patients with Obstructing Urolithiasis. J Endourol. 2017 Sep;31(9):942-945. doi: 10.1089/end.2017.0157. Epub 2017 Jun 27.
Fukushima H, Kobayashi M, Kawano K, Morimoto S. Performance of Quick Sequential (Sepsis Related) and Sequential (Sepsis Related) Organ Failure Assessment to Predict Mortality in Patients with Acute Pyelonephritis Associated with Upper Urinary Tract Calculi. J Urol. 2018 Jun;199(6):1526-1533. doi: 10.1016/j.juro.2017.12.052. Epub 2017 Dec 29.
Other Identifiers
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STU-2018-0028
Identifier Type: -
Identifier Source: org_study_id