Evaluation of Infection in Obstructing Urolithiasis

Sepsis Clinical Trial

— eIOU  

Official title:

Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04332861
• Other study ID #: STU-2018-0028
• Status: Completed
• Start date: September 3, 2019
• Est. completion date: July 28, 2020

Study information

• Verified date: December 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Communicable Diseases
• Infection
• Infections
• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Sepsis
• Urinary Calculi
• Urinary Tract Obstruction
• Urolithiasis

Intervention

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

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas
United States	UT Southwestern Medical Center Clements University Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary tract infection (positive urine culture)	Urinary tract infection, defined as a positive urine culture	Within 24-72 hours of initial clinical and laboratory evaluation
Primary	Intensive care unit admission and/or death due to sepsis during inpatient encounter	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	Bacteremia (at least one positive blood culture)	Bacteremia, defined as at least one positive blood culture	Within 24-72 hours of initial clinical and laboratory evaluation
Secondary	Pyonephrosis (drainage of pus from the involved kidney) during inpatient encounter	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