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

NCT04326517 — Unknown, 65 participants, Hospital Universitario Dr. Jose E. Gonzalez

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Microbiologic Profile And Factors Associated To Intensive Care Admission And Mortality In Patients With Emphysematous Pyelonephritis: A 10-Year Experience In A Tertiary Care Center

RegistryNCT04326517
StatusUnknown
Study typeObservational
Enrollment65 (Estimated)
SponsorHospital Universitario Dr. Jose E. Gonzalez (Other)
ConditionsEmphysematous Pyelonephritis
InterventionsNephrectomy (Procedure)
Datesstart 2020-04-01 (estimated), primary completion 2021-04-01 (estimated), completion 2021-04-01 (estimated), first posted 2020-03-30, last updated 2020-04-01
Locations1 site in Mexico

Related Papers Related Patents Related Grants Related Experts
All trials for Emphysematous Pyelonephritis All trials of Nephrectomy

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Emphysematous pyelonephritisProcedure: NephrectomyThis 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.
  • Nephrectomy (Procedure), also known as ureteral stent, percutaneous drainage, medical treatment: 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.

+Outcome measures

Primary outcomes

  • Number of patients with admission to Intensive care unit [10 years]: Patients with criteria to admit to intensive care unit
  • Rate of mortality [10 years]: Death cases during hospitalization

Secondary outcomes

  • Antibiotic susceptibility [10 years]: Drug resistance profile will be determined using microdilution plate.

+Eligibility

Sex: All, ages: 18 Years to any

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:

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

+Locations (1)

FacilityCityCountryStatus
Hospital Universitario "Dr. José Eleuterio González"Monterrey, Outside U.S./CanadaMexicoRecruiting

+Publications

  • Results publication: 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 6366247
  • Results publication: 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 7850302
  • Results publication: 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 20840327
  • Results publication: 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 11328918
  • Results publication: 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 10737279
  • Results publication: 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 17631348
  • Results publication: 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 2056576
  • Results publication: 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 18353396

+Investigators

  • Adrián Gutiérrez-González, PhD, Principal investigator, Universidad Autónoma de Nuevo León