Effect of Active Drain Line Clearance on Catheter-Associated Bacteriuria

NCT03816384 | Withdrawn DMC FDA Device

• 1 other identifier: CRD-06-100548
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

urinary catheter

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria

  30 days

• Time to Bacteriuria (ASB and CAUTI)

  30 days

• Urine Culture Comparisons

  30 days

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

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

Device: Standard of Care

Drain Line Clearance (DLC) Group

EXPERIMENTAL

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

Device: DLC Group

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.

Device: DLCS Group

Interventions

Standard of Care DEVICE

Standard of care urinary drainage system.

Standard of Care

DLC Group DEVICE

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

Drain Line Clearance (DLC) Group

DLCS Group DEVICE

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

Drain Line Clearance and Silver (DLCS) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (age ≥ 18)
• Patient or Legally Authorized Representative (LAR) possess the capacity to provide informed consent
• Indication for a urinary bladder catheter (or one currently in place)
• Expected urinary catheter requirement ≥ 72 hours
• No current urinary tract infection
• No current indication for prophylactic antibiotics. If a surgical patient, receive perioperative antibiotics for no greater than 24 hours

You may not qualify if:

• Inability to receive a urinary bladder catheter
• Chronic suprapubic catheter in place
• Expected survival \< 72 hours
• Receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery
• Surgery of the genitourinary tract in the past 6 months prior to admission
• Deemed unfit for the protocol by the investigator for any reason

Sponsors & Collaborators

• Potrero Medical: lead

MeSH Terms

Conditions

Critical Illness; Burns; Urinary Tract Infections; Bacteriuria

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kevin Foster, MD

  Maricopa Integrated Health System (MIHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, Randomized-Controlled-Trial

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 25, 2019
• Study Start: January 31, 2020
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share