Urinary Tract Infections in Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Urinary Tract Infections in Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05335213
• Other study ID #: 2.15
• Status: Recruiting
• Start date: January 5, 2022
• Est. completion date: April 5, 2024

Study information

• Verified date: April 2022
• Source: Gomel State Medical University
• Contact: Ekaterina Malaeva, PhD
• Phone: +375 29 338 07 08
• Email: dr-malaeva[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 5, 2024
• Est. primary completion date: April 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of cirrhosis

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Communicable Diseases
• Fibrosis
• Infections
• Liver Cirrhosis
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Belarus	Gomel State Clinical Hospital ?3	Gomel	Ilicha Str. 286

Sponsors (1)

Lead Sponsor	Collaborator
Gomel State Medical University

Country where clinical trial is conducted

Belarus, 

References & 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 — View Citation

Meštrovic T, Matijašic M, Peric M, Cipcic Paljetak H, Barešic 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). pii: E7. doi: 10.3390/diagnostics1101 — View Citation

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). pii: e00218-20. doi: 10.1128/mBio.00218-20. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Consequently, studying the relationship between gut microbiota and the subsequent development of bacteriuria and UTI represents an important field of research.
•   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.
•   The contribution of the urinary tract microbiome to urinary tract infection and recurrent urinary tract infection