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Declined to pursue Study due to anticipated low enrollment numbers
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Patients will receive Standard of Care, commercially available catheter utilized by hospital system. |
|
| Drain Line Clearance (DLC) Group | Experimental | Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter. |
|
| Drain Line Clearance and Silver (DLCS) Group | Experimental | Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Device | Standard of care urinary drainage system. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to Bacteriuria (ASB and CAUTI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Foster, MD | Maricopa Integrated Health System (MIHS) | Principal Investigator |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D002056 | Burns |
| D014552 | Urinary Tract Infections |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Multi-center, Randomized-Controlled-Trial
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| DLC Group |
| Device |
Urinary drainage system with active drain line clearance and plain silicone catheter. |
|
| DLCS Group | Device | Urinary drainage system with active drain line clearance and silver-doped silicone catheter. |
|
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 | To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag). | 30 days |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |