Clinical trial NCT04332861: Evaluation of Infection in Obstructing Urolithiasis
Official title: Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Stone
Kidney Calculi
Urinary Tract Obstruction
Infection
Sepsis
Keywords: Kidney Stone
Kidney Calculi
Urinary Tract Obstruction
Infection
Sepsis
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 477
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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

Primary outcomes:
measure: Urinary tract infection (positive urine culture)
timeFrame: Within 24-72 hours of initial clinical and laboratory evaluation
measure: Intensive care unit admission and/or death due to sepsis during inpatient encounter
timeFrame: On average within 24-72 hours after initial clinical and laboratory evaluation
Secondary outcomes:
measure: Bacteremia (at least one positive blood culture)
timeFrame: Within 24-72 hours of initial clinical and laboratory evaluation
measure: Pyonephrosis (drainage of pus from the involved kidney) during inpatient encounter
timeFrame: On average within 24-72 hours after initial clinical and laboratory evaluation
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center Clements University Hospital
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Jodi Antonelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Margaret S Pearle, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.