Clinical Trials Logo
  1. Home
  2. Intensive Care
  3. NCT00878683
  4. Details
NCT00878683 Clinical Trial

Novel Device for Reducing Catheter-Related Infections

Intensive Care Clinical Trial

Official title:
Exploring the Use of a Novel Device for Reducing Catheter-Related Bloodstream Infections

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00878683
Other study ID # 11525
Secondary ID
Status Withdrawn
Phase N/A
First received April 7, 2009
Last updated May 1, 2015
Start date July 2009
Est. completion date April 2011

Study information
Verified date May 2015
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is a pilot study of the safety, tolerability and efficacy of an investigational central venous catheter device used in conjunction with a standard central venous catheter. The hypothesis is that utilization of a catheter device incorporating cyanoacrylate will reduce catheter colonization by bacteria, and may decrease the rate of catheter-related bloodstream infections.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Admission in the ICU at time of catheter insertion

- Indication for central venous catheter placement

- De novo catheter insertion in the subclavian or internal jugular veins

Exclusion Criteria:

- Anticipated catheter duration < 72 hours

- Planned guidewire exchange

- Documented bacteremia within 48 hours prior to catheter placement

- Extensive skin breakdown near the site of potential catheter placement

- Emergent line placement

- Screening labs with ANC < 500 or platelets < 50K

- Hypersensitivity to cyanoacrylates or formaldehyde

- Prior enrollment in study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Device:
• silicone catheter boot
silicone device using Dermabond

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Kansas Medical Center University of Missouri-Columbia

Outcome
Type Measure Description Time frame Safety issue
Primary Catheter site inspection Baseline, Daily Yes
See also
  Status Clinical Trial Phase
Completed NCT00487097 - The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients N/A
Completed NCT01997931 - The Impact of Bispectral Index Monitoring on Sedation Administration in Mechanically Ventilated Patients N/A
Recruiting NCT04926220 - Dynamic Estimation of Cardiac Output in the Operating Room
Not yet recruiting NCT03617796 - Prognostic Value of CD64 Marker for Patients in Intensive Care Unit
Withdrawn NCT04554264 - Complicated Grief in ICU in the Aftermath of COVID-19 N/A
Recruiting NCT02587273 - The Pharmacokinetics of Fentanyl in Intensive Care Patients Phase 4
Withdrawn NCT01749488 - The Impact of a Dietitian in the Implementation of Nutrition Recommendations During Intensive Care N/A
Recruiting NCT06110390 - High-flow Nasal Oxygen Therapy to Prevent Extubation Failure in Adult Trauma Intensive Care Patients N/A
Completed NCT04186611 - Early Occupational Therapy in Intensive Care: Feasibility of Implementation N/A
Completed NCT03299894 - Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department N/A
Recruiting NCT03777150 - Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients? N/A
Completed NCT02583321 - Detection of Chlorhexidine in Tracheal Secretions After Routine Oral Care With Chlorhexidine Gluconate N/A
Completed NCT00787098 - Investigating Modes of Progressive Mobility Phase 2
Recruiting NCT04114747 - Renal Physiology During Continuous Renal Replacement Therapy N/A
Completed NCT02476591 - Charge Transparency in Critical Care Practice and Its Effects on Overall Cost of Care N/A
Completed NCT05795777 - Examination of the Pressure Ulcers in Intensive Care Patients.
Terminated NCT02587130 - Ketamine and Refractory Painful Care in a Palliative Unit Phase 4
Completed NCT02463123 - Energy Expenditure Estimation in Cardiac Surgery N/A
Completed NCT01607723 - "NAVA-PAV" Study: a Cross-over Comparative Study of 2 Advanced Modes Phase 3
Completed NCT01346813 - Epidemiology of Painful Procedures in Neonates N/A