Clinical trial NCT05335213: Urinary Tract Infections in Cirrhosis
Official title: Urinary Tract Infections in Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Urinary Tract Infections
Lead sponsor: Gomel State Medical University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective observational longitudinal multicenter study

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.

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.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cirrhosis

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants with variceal bleeding
timeFrame: 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
measure: Number of Participants with hepatic coma
timeFrame: 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
measure: Number of Participants with hepatorenal syndrome
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Gomel State Clinical Hospital №3
state: Ilicha Str. 286
Study officials:
affiliation: Gomel State Medical University
name: Igor Stoma, D.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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):e00218-20. doi: 10.1128/mBio.00218-20.