Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria (CAB)
Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.
Type d'étude
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Adult (age ≥ 18)
- Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
- Indication for a urinary bladder catheter (or one currently in place)
- Expected urinary catheter requirement ≥ 72 hours
- No current urinary tract infection
- No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours
Exclusion Criteria:
- Inability to receive a urinary bladder catheter
- Chronic suprapubic catheter in place
- Expected survival < 72 hours
- Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
- Surgery of the genitourinary tract in the past 6 months prior to admission
- Deemed unfit for the protocol by the investigator for any reason
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Standard of Care
Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
|
Standard of care urinary drainage system.
|
|
Expérimental: Drain Line Clearance (DLC) Group
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.
|
Urinary drainage system with active drain line clearance and plain silicone catheter.
|
|
Expérimental: Drain Line Clearance and Silver (DLCS) Group
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
|
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Difference in percentage of catheter-associated bacteriuria
Délai: 30 days
|
To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
|
30 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
Délai: 30 days
|
To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
|
30 days
|
|
Time to Bacteriuria (ASB and CAUTI)
Délai: 30 days
|
To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
|
30 days
|
|
Urine Culture Comparisons
Délai: 30 days
|
To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
|
30 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kevin Foster, MD, Maricopa Integrated Health System (MIHS)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRD-06-100548
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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