Urinary Tract Infections in Cirrhosis

NCT05335213 | Unknown

• 1 other identifier: 2.15
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Cirrhosis; Urinary Tract Infections

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Participants with cirrhosis and urinary tract infections

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

Participants with cirrhosis without urinary tract infections

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

Interventions

16S rRNA gene sequencing DIAGNOSTIC_TEST

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.

Participants with cirrhosis and urinary tract infections; Participants with cirrhosis without urinary tract infections

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prospective observational longitudinal multicenter study

You may qualify if:

• clinical diagnosis of cirrhosis

You may not qualify if:

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

Sponsors & Collaborators

• Gomel State Medical University: lead

Study Sites (1)

Gomel State Clinical Hospital №3

Homyel, Ilicha Str. 286, 246013, Belarus

RECRUITING

Related Publications (3)

• Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.

  PMID: 20558165 RESULT

• Mestrovic T, Matijasic M, Peric M, Cipcic Paljetak H, Baresic A, Verbanac D. The Role of Gut, Vaginal, and Urinary Microbiome in Urinary Tract Infections: From Bench to Bedside. Diagnostics (Basel). 2020 Dec 22;11(1):7. doi: 10.3390/diagnostics11010007.

  PMID: 33375202 RESULT

• Neugent ML, Hulyalkar NV, Nguyen VH, Zimmern PE, De Nisco NJ. Advances in Understanding the Human Urinary Microbiome and Its Potential Role in Urinary Tract Infection. mBio. 2020 Apr 28;11(2):e00218-20. doi: 10.1128/mBio.00218-20.

  PMID: 32345639 RESULT

Related Links

• In patients with cirrhosis, infections increase mortality 4-fold; 30% of patients die within 1 month after infection and another 30% die by 1 year.
• Consequently, studying the relationship between gut microbiota and the subsequent development of bacteriuria and UTI represents an important field of research.
• The contribution of the urinary tract microbiome to urinary tract infection and recurrent urinary tract infection

Biospecimen

Retention: SAMPLES WITH DNA

The urine and fecal specimens collect and store at -80°C

MeSH Terms

Conditions

Liver Cirrhosis; Urinary Tract Infections

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Igor Stoma, D.Sc.

  Gomel State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekaterina Malaeva, PhD

CONTACT

+375 29 338 07 08; dr-malaeva@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: January 5, 2022
• Primary Completion: April 10, 2022
• Study Completion: April 5, 2024
• Last Updated: April 19, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)