Clinical trial NCT03816384: Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria
Official title: Effect of Active Drain Line Clearance With or Without Silver on Catheter-Associated Bacteriuria (The CAB Study)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Critical Illness
Burns
Surgery
Urinary Tract Infections
Bacteriuria
Keywords: urinary catheter
Lead sponsor: Potrero Medical
Sponsor class: INDUSTRY
First posted: 2019-01-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, Randomized-Controlled-Trial
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in percentage of catheter-associated bacteriuria
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
timeFrame: 30 days
measure: Time to Bacteriuria (ASB and CAUTI)
timeFrame: 30 days
measure: Urine Culture Comparisons
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Maricopa Integrated Health System (MIHS)
name: Kevin Foster, MD
role: PRINCIPAL_INVESTIGATOR
References: