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Status unknownNCT04326517Updated Apr 1, 2020

Factors Associated To Intensive Care Admission And Mortality In Patients With Emphysematous Pyelonephritis

An observational study in Emphysematous Pyelonephritis, sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Status unknown at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-01.

Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study summary

Emphysematous pyelonephritis is a lifethreatening necrotizing infection of the kidney characterized by accumulation of gas in the renal parenchyma and within the surrounding tissues. The aim of the study is to report the outcome of the management of this condition at the investigators institution and to determine the microbiological characteristics, antibiotic resistance patterns, and to analyze factors predicting mortality and intensive care unit admission.

Read the detailed description

The investigators are planning to perform a retrospective study analyzing cases of emphysematous pyelonephritis from a single tertiary care institution in the north of Mexico in the period of 2011-2021. The diagnosis of emphysematous pyelonephritis is confirmed by computed tomography. Demographic, clinical, biochemical, therapeutic management, and outcomes will be collected. Variables will be analyzed to determine factors associated with admission to intensive care unit and mortality. Urine cultures will be analyzed and drug resistance profile will be determined using microdilution plate. Clinical and demographic characteristics will be analyzed using Chi square test for categorical variables, and T-test for numerical variables. Statistical significance is set at p\<0.05. Statistical analysis will be performed with the SPSS software version 20.0.

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Conditions studied

  • Emphysematous Pyelonephritis

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Keywords

  • emphysematous pyelonephritis
  • intensive care unit
  • mortality
  • risk factors
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a confirmatory diagnosis using emphysematous pyelonephritis by computed tomography are included, as well as signs and symptoms of upper urinary tract infection and data of systemic inflammatory response. Participants are usually admitted to the emergency room and recruited for analysis during hospitalization.

Inclusion criteria

  • Emphysematous pyelonephritis confirmed with computed tomography
  • Systemic inflammatory response
  • Urinary tract infection symptoms
  • Complete medical records
  • Both genders included
  • >18 years old

Exclusion criteria

Exclusion Criteria:

  • Other infectious causes
  • Asymptomatic bacteriuria
  • Incomplete medical records
  • Endourologic procedure 3 months before recruitment
04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
65 participants (estimated)
Patient registry
No

Groups and cohorts

  • Emphysematous pyelonephritis

    This is a single-group cohort study. A sub-classification will be used in order to differentiate patients that did not require intensive care, the ones who admitted to intensive care and mortality.

    Procedure: Nephrectomy

Interventions

  • ProcedureNephrectomy

    Different therapeutic options are described in literature for emphysematous pyelonephritis. In our center, medical treatment (no invasive procedure), ureteral stent (endourologic procedure), percutaneous drainage (minimally invasive procedure), and nephrectomy are the therapeutic options for this disease.

    Also known as: ureteral stent, percutaneous drainage, medical treatment

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What researchers measure

Primary outcomes

  1. Number of patients with admission to Intensive care unit

    Patients with criteria to admit to intensive care unit

    Time frame: 10 years

  2. Rate of mortality

    Death cases during hospitalization

    Time frame: 10 years

Secondary outcomes

  1. Antibiotic susceptibility

    Drug resistance profile will be determined using microdilution plate.

    Time frame: 10 years

06

Study locations

1 of 1 sites recruiting
  • Hospital Universitario "Dr. José Eleuterio González"
    Monterrey, Outside U.S./Canada 64634, Mexico
    Recruiting
07

References and documents

Publications

  • Michaeli J, Mogle P, Perlberg S, Heiman S, Caine M. Emphysematous pyelonephritis. J Urol. 1984 Feb;131(2):203-8. doi: 10.1016/s0022-5347(17)50309-2. No abstract available. PubMed 6366247 ↗
  • Pontin AR, Barnes RD, Joffe J, Kahn D. Emphysematous pyelonephritis in diabetic patients. Br J Urol. 1995 Jan;75(1):71-4. doi: 10.1111/j.1464-410x.1995.tb07237.x. PubMed 7850302 ↗
  • Ubee SS, McGlynn L, Fordham M. Emphysematous pyelonephritis. BJU Int. 2011 May;107(9):1474-8. doi: 10.1111/j.1464-410X.2010.09660.x. Epub 2010 Sep 14. PubMed 20840327 ↗
  • Kumar A, Turney JH, Brownjohn AM, McMahon MJ. Unusual bacterial infections of the urinary tract in diabetic patients--rare but frequently lethal. Nephrol Dial Transplant. 2001 May;16(5):1062-5. doi: 10.1093/ndt/16.5.1062. No abstract available. PubMed 11328918 ↗
  • Huang JJ, Tseng CC. Emphysematous pyelonephritis: clinicoradiological classification, management, prognosis, and pathogenesis. Arch Intern Med. 2000 Mar 27;160(6):797-805. doi: 10.1001/archinte.160.6.797. PubMed 10737279 ↗
  • Falagas ME, Alexiou VG, Giannopoulou KP, Siempos II. Risk factors for mortality in patients with emphysematous pyelonephritis: a meta-analysis. J Urol. 2007 Sep;178(3 Pt 1):880-5; quiz 1129. doi: 10.1016/j.juro.2007.05.017. Epub 2007 Jul 16. PubMed 17631348 ↗
  • Huang JJ, Chen KW, Ruaan MK. Mixed acid fermentation of glucose as a mechanism of emphysematous urinary tract infection. J Urol. 1991 Jul;146(1):148-51. doi: 10.1016/s0022-5347(17)37736-4. PubMed 2056576 ↗
  • Somani BK, Nabi G, Thorpe P, Hussey J, Cook J, N'Dow J; ABACUS Research Group. Is percutaneous drainage the new gold standard in the management of emphysematous pyelonephritis? Evidence from a systematic review. J Urol. 2008 May;179(5):1844-9. doi: 10.1016/j.juro.2008.01.019. Epub 2008 Mar 19. PubMed 18353396 ↗

Individual participant data

Plan to share: Yes — An e-mail contact of the research party will be published in order to share information of our data, excel databases and other type of information.

Supporting information: Study protocol, Sap

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Registry details

Key details

Study ID
NCT04326517
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Responsible party
Adrián Gutiérrez González (Head of Urology Department, Hospital Universitario Dr. Jose E. Gonzalez) — Principal investigator
First posted
Mar 30, 2020
Start date
Apr 1, 2020 (estimated)
Primary completion
Apr 1, 2021 (estimated)
Completion
Apr 1, 2021 (estimated)
Last update
Apr 1, 2020

Study contacts

Jose I Robles-Torres, M.D.
Contact
ivan.robles25@live.com
+526531191450
Marco A Ocaña-Munguía, M.D.
Contact
mocana94@gmail.com
+528113112108
Adrián Gutiérrez-González, PhD
principal investigator · Universidad Autónoma de Nuevo León

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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