Gentamicin Bladder Instillation on CAUTI
ConditionCatheter Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Hospital and Medical Center, Phoenix
About this trial
Urinary tract infections in catheterized patients is an unacceptable complication and has been termed a 'never event' by the Center for Medicare \& Medicaid Services (CMS); however there is not consensus among clinicians on how to best prevent CAUTIs. We propose a prospective randomized controlled trial to test the efficacy of prophylactic gentamicin bladder irrigation in elimination of CAUTIs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age greater than 18
admitted with a trauma, surgical, or neuro-critical care diagnosis
indwelling foley catheter in place
Disqualifiers
Documented positive UA or Urine Culture within the past 7 days or upon admission
Traumatic bladder injury
Gross hematuria
Chronic indwelling urethral or chronic suprapubic foley catheter
Trial design
Design model
Parallel
Treatments tested in this trial
Gentamicin
Drugrandom assignment to gentamicin or placebo bladder instillation to prevent CAUTI (catheterized urinary track infection)
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: GentamicinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
CAUTI as primary outcome
positive urine culture
Time frame
30 daysSponsors and contacts
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Source ClinicalTrials.gov