Clinical trial NCT04326517: Factors Associated To Intensive Care Admission And Mortality In Patients With Emphysematous Pyelonephritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emphysematous Pyelonephritis
Keywords: emphysematous pyelonephritis
intensive care unit
mortality
risk factors
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with admission to Intensive care unit
timeFrame: 10 years
measure: Rate of mortality
timeFrame: 10 years
Secondary outcomes:
measure: Antibiotic susceptibility
timeFrame: 10 years
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. José Eleuterio González"
state: Outside U.S./Canada
Study officials:
affiliation: Universidad Autónoma de Nuevo León
name: Adrián Gutiérrez-González, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.