NCT05335213

Urinary Tract Infections in Cirrhosis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 35 (estimated)
• Sponsor: Gomel State Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the prevalence and types of urinary tract infections, the features of the gut and urinary tract microbiota in cirrhosis, to assess its importance in the development of complications and outcomes of cirrhosis.

Detailed description

Asymptomatic bacteriuria in an individual without urinary tract symptoms is defined by a mid-stream sample of urine showing bacterial growth \> 105 cfu/mL in two consecutive samples in women and in one single sample in men. A complicated urinary tract infections occurs in an individual in whom factors related to the host (e.g. underlying diabetes or immunosuppression) or specific anatomical or functional abnormalities related to the urinary tract. Laboratory urine culture is the recommended method to determine the presence or absence of clinically significant bacteriuria. Catheter-associated urinary tract infections refers to urinary tract infections occurring in a person whose urinary tract is currently catheterised or has been catheterised within the past 48 hours. Signs and systemic symptoms compatible with сatheter-associated urinary tract infections include new onset or worsening of fever, rigors, altered mental status, malaise, or lethargy with no other identified cause, flank pain, costovertebral angle tenderness, acute haematuria, pelvic discomfort and in those whose catheters have been removed dysuria, urgent or frequent urination and suprapubic pain or tenderness. Microbiologically, сatheter-associated urinary tract infections is defined by microbial growth of \> 103 cfu/mL of one or more bacterial species in a single catheter urine specimen or in a mid-stream voided urine specimen from a patient whose urethral, suprapubic, or condom catheter has been removed within the previous 48 hours.

Conditions

• Liver Cirrhosis
• Urinary Tract Infections

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	16S rRNA gene sequencing	DNA extraction and 16S rRNA gene sequencing DNA extraction, 16S rRNA gene amplification, and deep sequencing of the 16S rRNA amplicon performe. The V4-V5 region of the 16S rRNA gene amplify with barcodes for multiplexing.

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-04-10
• Completion: 2024-04-05
• First posted: 2022-04-19
• Last updated: 2022-04-19

Locations

1 site across 1 country: Belarus