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

Emphysematous Pyelonephritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326517
• Other study ID #: UR 18-00008
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: March 2020
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Jose I Robles-Torres, M.D.
• Phone: +526531191450
• Email: ivan.robles25[@]live.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emphysematous Pyelonephritis
• Pyelonephritis

Intervention

Procedure:
• Nephrectomy
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.

Locations

Country	Name	City	State
Mexico	Hospital Universitario "Dr. José Eleuterio González"	Monterrey	Outside U.S./Canada

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez

Country where clinical trial is conducted

Mexico, 

References & Publications (8)

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. Epub 2007 Jul 16. — View 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. — View Citation

Huang JJ, Tseng CC. Emphysematous pyelonephritis: clinicoradiological classification, management, prognosis, and pathogenesis. Arch Intern Med. 2000 Mar 27;160(6):797-805. — View 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. — View Citation

Michaeli J, Mogle P, Perlberg S, Heiman S, Caine M. Emphysematous pyelonephritis. J Urol. 1984 Feb;131(2):203-8. Review. — View Citation

Pontin AR, Barnes RD, Joffe J, Kahn D. Emphysematous pyelonephritis in diabetic patients. Br J Urol. 1995 Jan;75(1):71-4. — View 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: 10.101 — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with admission to Intensive care unit	Patients with criteria to admit to intensive care unit	10 years
Primary	Rate of mortality	Death cases during hospitalization	10 years
Secondary	Antibiotic susceptibility	Drug resistance profile will be determined using microdilution plate.	10 years