Urinary Tract Infections in Cirrhosis

Gomel State Medical University

Status: Unknown

Conditions: Urinary Tract Infections; Liver Cirrhosis

Treatments: Diagnostic Test: 16S rRNA gene sequencing

Study type: Observational

Funder types: Other

Identifiers

NCT05335213

2.15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of cirrhosis

Exclusion criteria

• human immunodeficiency virus or acquired immune deficiency syndrome
• autoimmune diseases
• oncology
• organ transplantation

Trial design

35 participants in 2 patient groups

Participants with cirrhosis and urinary tract infections

Description:

Participants collect urine and fecal specimens at first two days when they admit to hospital, after 7-10 days and last two days hospital treatment and during episodes of complications (variceal bleeding, hepatic coma, hepatorenal syndrome). Urine samples take from patients via clean catch if the patient not have a catheter placed, otherwise take from urinary catheters if present. Straight catheterization utilize if the patient unable to void and doesn't have a catheter placed. Fecal specimens collect using a toilet specimen collection kit. Clinical, standart laboratory and cultural test, molecular genetic methods, using 16S rRNA gene sequencing of the V4-V5 hypervariable region be administered.

Treatment:

Diagnostic Test: 16S rRNA gene sequencing

Participants with cirrhosis without urinary tract infections

Description:

Participants ask to collect urine and fecal specimens at first two days when they admit to hospital, after 7-10 days and last two days hospital treatment and during episodes of complications (variceal bleeding, hepatic coma, hepatorenal syndrome). Urine samples take from patients via clean catch if the patient not have a catheter placed, otherwise take from urinary catheters if present. Straight catheterization utilize if the patient unable to void and doesn't have a catheter placed. Fecal specimens collect using a toilet specimen collection kit. Clinical, standart laboratory and cultural test, molecular genetic methods, using 16S rRNA gene sequencing of the V4-V5 hypervariable region be administered.

Treatment:

Diagnostic Test: 16S rRNA gene sequencing