Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients
NCT07719673
Bacterial Colonization, Critical Illness
Cluj-Napoca, Romania
View Trial DetailsNCT Number: NCT07760792
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and stent cultures will be obtained. The study will assess the association between colonization and factors such as indwelling time, diabetes mellitus, chronic kidney disease, prior urinary tract infection, prior antibiotic exposure, and stent-related symptoms.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
This prospective observational cohort study will enroll adult patients undergoing temporary Double-J ureteral stent insertion at Al-Azhar University hospitals in Cairo, Egypt. Participants will be followed from stent insertion until removal. Baseline demographic, clinical, and laboratory data will be collected, together with stent-related variables such as stent side, size, material, and indwelling time. Midstream urine culture will be obtained when feasible before insertion and again at removal, and the stent will be cultured under sterile conditions at removal.
The primary outcome is bacterial colonization of the Double-J stent, defined as positive growth on stent culture at removal. Secondary outcomes include positive urine culture, febrile urinary tract infection, concordance between urine and stent cultures, antimicrobial resistance patterns, stent-related symptom burden, and need for hospitalization or additional treatment. Risk factors for colonization will be analyzed using multivariable logistic regression.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Positive growth on stent culture at removal.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Positive midstream urine culture during stent indwelling or at removal.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Development of urinary tract infection while the stent is in place; Confirmed by Clinical Assessment and Urine Culture
Time frame: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Agreement between urine culture and stent culture, assessed by Cohen's kappa coefficient
Time frame: At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Resistance pattern of organisms isolated from urine and stent cultures.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Symptoms such as flank pain, dysuria, hematuria, frequency, and urgency, assessed by questionnaire if available.
Time frame: From stent insertion until stent removal, assessed up to 52 weeks after insertion.
Need for emergency visit, admission, or additional treatment related to stent-associated complications.
Contact information is provided by the study sponsor or research team.
Al-Azhar University
Other
Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
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