Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

Surgery Clinical Trial

— CAB  

Official title:

Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03816384
• Other study ID #: CRD-06-100548
• Status: Withdrawn
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: January 31, 2020

Study information

• Verified date: January 2020
• Source: Potrero Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult (age = 18)

2. Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent

3. Indication for a urinary bladder catheter (or one currently in place)

4. Expected urinary catheter requirement = 72 hours

5. No current urinary tract infection

6. No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

Exclusion Criteria:

1. Inability to receive a urinary bladder catheter

2. Chronic suprapubic catheter in place

3. Expected survival < 72 hours

4. Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery

5. Surgery of the genitourinary tract in the past 6 months prior to admission

6. Deemed unfit for the protocol by the investigator for any reason

Related Conditions & MeSH terms

• Bacteriuria
• Burns
• Critical Illness
• Surgery
• Urinary Tract Infections

Intervention

Device:
• Standard of Care
Standard of care urinary drainage system.
• DLC Group
Urinary drainage system with active drain line clearance and plain silicone catheter.
• DLCS Group
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Potrero Medical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in percentage of catheter-associated bacteriuria	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
Secondary	Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria	To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.	30 days
Secondary	Time to Bacteriuria (ASB and CAUTI)	To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.	30 days
Secondary	Urine Culture Comparisons	To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).	30 days