Kidney StoneeIOUNCT04332861
Evaluation of Infection in Obstructing Urolithiasis
An observational study of Kidney Stone and Kidney Calculi, run by University of Texas Southwestern Medical Center at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone, Kidney Calculi, Urinary Tract Obstruction
- What is being tested?
- Initial clinical and laboratory evaluation
- How many people
- 477 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2019to 28 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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).
Who may be able to join
- Men and women 18 and older
- Acute presentation of obstructing urolithiasis diagnosed on CT
Who cannot join
- Indwelling nephrostomy tubes or ureteral stents
- Staghorn calculi or evidence of xanthogranulomatous pyelonephritis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Memorial Hospital
Dallas, Texas, 75235
UT Southwestern Medical Center Clements University Hospital
Dallas, Texas, 75235
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection, Sepsis
- Being tested
- Initial clinical and laboratory evaluation
- Keywords
- Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection, Sepsis
- Medical subject headings
- Kidney Calculi, Infections, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial clinical and laboratory evaluationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Initial clinical and laboratory evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary tract infection (positive urine culture)
Urinary tract infection, defined as a positive urine culture
Measured: Within 24-72 hours of initial clinical and laboratory evaluation
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.
Measured: On average within 24-72 hours after initial clinical and laboratory evaluation
Secondary outcomes (2)
Bacteremia (at least one positive blood culture)
Bacteremia, defined as at least one positive blood culture
Measured: Within 24-72 hours of initial clinical and laboratory evaluation
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
Measured: On average within 24-72 hours after initial clinical and laboratory evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start3 Sep 2019
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Pearle, University of Texas Southwestern Medical Center
- Investigators
- Jodi Antonelli, MD, Principal investigator, University of Texas Southwestern Medical CenterMargaret S Pearle, MD PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332861
- Sponsor's protocol ID
- STU-2018-0028
- Acronym
- eIOU
- Status last verified
- Dec 2023
- First submitted
- 30 Mar 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27238616Borofsky 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.
PubMed 23017519Pearle 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.
PubMed 9751331Singer 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.
PubMed 26903338Abrahamian 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.
PubMed 23850311Cheung 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.
PubMed 28558478Fukushima 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.
PubMed 29291417
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Infection in Obstructing Urolithiasis: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04332861
- Acronym / sponsor ID
- eIOU / STU-2018-0028
- Conditions
- Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection, Sepsis
- Keywords
- Kidney Stone, Kidney Calculi, Urinary Tract Obstruction, Infection, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective observational cohort | – | Other: Initial clinical and laboratory evaluationFor 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Men and women 18 and older
- Acute presentation of obstructing urolithiasis diagnosed on CT
Key exclusion criteria (2 listed)
- Indwelling nephrostomy tubes or ureteral stents
- Staghorn calculi or evidence of xanthogranulomatous pyelonephritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial clinical and laboratory evaluationInitial 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 | Other | Prospective observational cohort |
Primary outcome
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
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.
2 secondary outcomes
Bacteremia (at least one positive blood culture)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Background: PubMed 27238616Assimos 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.
- Background: PubMed 23017519Borofsky 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.
- Background: PubMed 9751331Pearle 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.
- Background: PubMed 26903338Singer 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.
- Background: PubMed 23850311Abrahamian 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.
- Background: PubMed 28558478Cheung 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.
- Background: PubMed 29291417Fukushima 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodi Antonelli, MD principal investigator
University of Texas Southwestern Medical Center
Margaret S Pearle, MD PhD principal investigator
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Stone and Kidney Calculi, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary tract infection (positive urine culture) (time frame: Within 24-72 hours of initial clinical and laboratory evaluation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332861, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.