Urinary Tract Infections in Cirrhosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urinary Tract Infections in Cirrhosis

Conditions
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Urinary Tract Infections, Liver Cirrhosis

Intervention / Treatment
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* Diagnostic Test: 16S rRNA gene sequencing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of cirrhosis Exclusion Criteria: human immunodeficiency virus or acquired immune deficiency syndrome autoimmune diseases oncology organ transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with cirrhosis and urinary tract infections<br>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. | Diagnostic Test: 16S rRNA gene sequencing<br>* 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.<br>|
| Participants with cirrhosis without urinary tract infections<br>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. | Diagnostic Test: 16S rRNA gene sequencing<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with variceal bleeding | The main diagnostic method of variceal bleeding is endoscopy | from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 3 months | 
| Number of Participants with hepatic coma | hepatic encephalopathy is graded with the West Haven Criteria: Grade 0 - No obvious changes other than a potentially mild decrease in intellectual ability and coordination Grade 1 - Trivial lack of awareness; euphoria or anxiety; shortened attention span; impaired performance of addition or subtraction Grade 2 - Lethargy or apathy; minimal disorientation for time or place; subtle personality change; inappropriate behaviour Grade 3 - Somnolence to semistupor, but responsive to verbal stimuli; confusion; gross disorientation Grade 4 - Coma | from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 3 months | 
| Number of Participants with hepatorenal syndrome | Type-1 hepatorenal syndrome is characterized by a rapid deterioration of renal function with a doubling of serum creatinine to values above 2.5 mg/dl within 2 weeks, type-2 hepatorenal syndrome is characterized by a slower increase in serum creatinine to values above 1.5 mg/dl. The main clinical characteristic of Type-1 hepatorenal syndrome is acute renal failure, while the main characteristic of type-2 hepatorenal syndrome is refractory ascites. | from the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 3 months |