NCT04326517

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

March 26, 2020

Last Update Submit

March 30, 2020

Conditions

Emphysematous Pyelonephritis

Keywords

emphysematous pyelonephritisintensive care unitmortalityrisk factors

Outcome Measures

Primary Outcomes (2)

  • Number of patients with admission to Intensive care unit

    Patients with criteria to admit to intensive care unit

    10 years

  • Rate of mortality

    Death cases during hospitalization

    10 years

Secondary Outcomes (1)

  • Antibiotic susceptibility

    10 years

Study Arms (1)

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

NephrectomyPROCEDURE

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
Emphysematous pyelonephritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Dr. José Eleuterio González"

Monterrey, Outside U.S./Canada, 64634, Mexico

RECRUITING

Related Publications (8)

  • 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.

    PMID: 6366247RESULT

  • 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.

    PMID: 7850302RESULT

  • 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.

    PMID: 20840327RESULT

  • 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.

    PMID: 11328918RESULT

  • 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.

    PMID: 10737279RESULT

  • 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.

    PMID: 17631348RESULT

  • 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.

    PMID: 2056576RESULT

  • 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.

    PMID: 18353396RESULT

MeSH Terms

Conditions

Emphysematous Pyelonephritis

Interventions

Nephrectomy

Condition Hierarchy (Ancestors)

PyelonephritisNephritis, InterstitialNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPyelitisMale Urogenital DiseasesEmphysemaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Adrián Gutiérrez-González, PhD

    Universidad Autónoma de Nuevo León

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose I Robles-Torres, M.D.

CONTACT

+526531191450ivan.robles25@live.com

Marco A Ocaña-Munguía, M.D.

CONTACT

+528113112108mocana94@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Urology Department

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 1, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
after recruitment period has concluded.
Access Criteria
By e-mail, any author will be available in order to support and facilitate requested information.

Locations

ME(1)