Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

NCT ID: NCT03816384

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2020-01-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DEVICE

Standard of care urinary drainage system.

Drain Line Clearance (DLC) Group

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

Group Type: EXPERIMENTAL

DLC Group

Intervention Type: DEVICE

Urinary drainage system with active drain line clearance and plain silicone catheter.

Drain Line Clearance and Silver (DLCS) Group

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

Group Type: EXPERIMENTAL

DLCS Group

Intervention Type: DEVICE

Urinary drainage system with active drain line clearance and silver-doped silicone catheter.

Interventions

Standard of Care

Standard of care urinary drainage system.

Intervention Type: DEVICE

DLC Group

Urinary drainage system with active drain line clearance and plain silicone catheter.

Intervention Type: DEVICE

DLCS Group

Urinary drainage system with active drain line clearance and silver-doped silicone catheter.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Potrero Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Foster, MD

Role: PRINCIPAL_INVESTIGATOR

Maricopa Integrated Health System (MIHS)

Other Identifiers

CRD-06-100548

Identifier Type: -

Identifier Source: org_study_id