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

• Conditions: Emphysematous Pyelonephritis
• Interventions: Procedure: Nephrectomy

• Registration Number: NCT04326517
• Lead Sponsor: Hospital Universitario Dr. Jose E. Gonzalez

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study Start: 2020-04-01
• Last Update Posted: 2020-04-01
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emphysematous pyelonephritis	Nephrectomy	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Antibiotic susceptibility	10 years	Drug resistance profile will be determined using microdilution plate.

Trial Locations

Locations (1)

Hospital Universitario "Dr. José Eleuterio González"; 🇲🇽 Monterrey, Outside U.S./Canada, Mexico