Bacteriuria, Burns, Critical Illness, Surgery, Urinary Tract Infections
Conditions
Keywords
urinary catheter
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.
Interventions
DEVICEStandard of Care
Standard of care urinary drainage system.
DEVICEDLC Group
Urinary drainage system with active drain line clearance and plain silicone catheter.
DEVICEDLCS Group
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
Sponsors
Potrero Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multi-center, Randomized-Controlled-Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in percentage of catheter-associated bacteriuria | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria | 30 days | To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours. |
| Time to Bacteriuria (ASB and CAUTI) | 30 days | To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours. |
| Urine Culture Comparisons | 30 days | To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag). |
Outcome results
None listed