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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Standard of Care
Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
|
Standard of care urinary drainage system.
|
|
Experimental: 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Difference in percentage of catheter-associated bacteriuria
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Kevin Foster, MD, Maricopa Integrated Health System (MIHS)
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRD-06-100548
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .