Urinary Tract Infection in Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Urinary Tract Infection in Patients With Chronic Kidney Disease: A Retrospective Observational Study at Outpatient Nephrology Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674942
• Other study ID #: Urinary Tract Infection
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: June 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the etiology and associated risk factors for UTI in Egyptian chronic kidney disease patients. In addition, to identify the isolated micro-organisms and their sensitivity patterns for better anticipation of treatment regimen.

Description:

Chronic kidney disease (CKD) patients are at higher risk of urinary tract infections (UTI), as CKD is a state of chronic inflammation, metabolic disturbance and impaired immunocompetence. Moreover, patient with CKD are usually of advanced age and suffer from other comorbidities such as diabetes, hypertension, obesity, and cardiovascular diseases, which also add to their risk of infection.

UTI comprises heterogeneous conditions ranging from mild cystitis, easily treated with oral antibiotics, to life-threatening sepsis and multiple organ failure.

There is scarce information about risk factors of recurrence of UTI and infection with multidrug-resistant organisms in the Egyptian population.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males and non-pregnant females aged = 18 years old

2. Patients with CKD stages (G1 to G4)

3. Patients diagnosed with UTI due to urine culture

Exclusion Criteria:

1. Non-CKD patients

2. pregnant females

3. CKD patients on immunosuppressant agents

4. ESRD patients on hemodialysis

5. Patients with structural abnormalities which make them liable to frequent UTI

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Communicable Diseases
• Infections
• Kidney Diseases
• Renal Insufficiency, Chronic
• Urinary Tract Infections

Intervention

Other:
• Patients with urinary tract infection and chronic kidney disease
The data that will be collected from the electronic patient records at the clinics through a google form will include sociodemographic (age, sex, weight and occupation), comorbidities (e.g., HTN, DM), medications used, renal functions (serum creatinine, and CKD stage calculated by 2021 CKD-EPI creatinine equation), and in case of positive urine culture (type of microorganism and antibiogram).

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Dimitrijevic Z, Paunovic G, Tasic D, Mitic B, Basic D. Risk factors for urosepsis in chronic kidney disease patients with urinary tract infections. Sci Rep. 2021 Jul 13;11(1):14414. doi: 10.1038/s41598-021-93912-3. — View Citation

Gouda Z, Mashaal G, Bello AK, El Attar A, El Kemmry T, El Reweny A, El Nahas M. Egypt Information, Prevention, and Treatment of Chronic Kidney Disease (EGIPT-CKD) programme: prevalence and risk factors for microalbuminuria among the relatives of patients with CKD in Egypt. Saudi J Kidney Dis Transpl. 2011 Sep;22(5):1055-63. — View Citation

Scherberich JE, Funfstuck R, Naber KG. Urinary tract infections in patients with renal insufficiency and dialysis - epidemiology, pathogenesis, clinical symptoms, diagnosis and treatment. GMS Infect Dis. 2021 Dec 21;9:Doc07. doi: 10.3205/id000076. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of UTI in CKD patients	percentage of UTI in CKD patients	records will be retrospectively screened from January 2019 till September 2022
Primary	isolated microorganisms causing UTI in CKD patients	isolated microorganisms in cultures causing UTI in CKD patients	records will be retrospectively screened from January 2019 till September 2022
Secondary	sensitivity pattern of urine cultures in CKD	describe sensitivity pattern of urine cultures in CKD	records will be retrospectively screened from January 2019 till September 2022