Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria (CAB)

Potrero Medical

Status: Withdrawn

Conditions: Urinary Tract Infections; Surgery; Critical Illness; Bacteriuria; Burns

Treatments: Device: Standard of Care; Device: DLCS Group; Device: DLC Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT03816384

CRD-06-100548

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

Patients will receive Standard of Care, commercially available catheter utilized by hospital system.

Treatment:

Device: Standard of Care

Drain Line Clearance (DLC) Group

Experimental group

Description:

Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.

Treatment:

Device: DLC Group

Drain Line Clearance and Silver (DLCS) Group

Experimental group

Description:

Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.

Treatment:

Device: DLCS Group