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Device for Bacteremia Prevention in Post Cardiac Surgical Intensive Care Unit Patients

NCT03309137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-05

No results posted yet for this study

Summary

Intravenous catheters are often placed in large (central) veins in critically ill patients to provide special medications or frequent blood sampling. The body reacts to the presence of foreign material by forming a biofilm on the surface within the catheter. Either due to the patients condition or to emergency access to these intravenous lines can become infected with bacteria and reside within the biofilm. When bacteria is grown from these lines it is referred to as: a central line infection. A medical device company (ICU Medical) has obtained the rights to a device that delivers a controlled amount of a cleaning material called chlorhexidine into the catheter to prevent bacterial growth when not in use. Chlorhexidine is the standard cleaning material used on patients when cleaning the skin for surgical procedures or central intravenous catheter insertion. In laboratory tests and animal studies that chlorhexidine inhibits the growth of bacteria and fungi that often cause central line infections. This study will the first assessment in patients with central lines.

Conditions

  • Infection
  • Heart; Surgery, Heart, Functional Disturbance as Result
  • Bacteremia

Interventions

DEVICE

Chlorhexidine flush

1. For patients randomized to the CHG-LockTM device, attach a attach a BD Posiflush ™ 0.9% Sodium Chloride (Na Cl) 10ml syringe and a CHG-Lock™ device for each IV line that is to be locked. Follow hospital approved protocol for flush, volumes and hand hygiene. After a Catheter has been locked, before re-accessing the catheter for further sampling or infusions, all fluid should be aspirated from the catheter to clear the device of CHG, Heparin and the like. This should also confirm patency of the device. 2. Discard the syringe and device in biohazard waste. 3. "Blue Cap" the IV as per routine practice.

Sponsors & Collaborators

  • Dr. Richard Whitlock

    collaborator UNKNOWN

  • Dr. Julian Owen

    collaborator UNKNOWN

  • Pamela Benoit, RN

    collaborator UNKNOWN

  • Alison Fox-Robichaud

    lead OTHER

Principal Investigators

  • Alison Fox-Robichaud, MD · Hamilton Health Sciences Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-19
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03309137 on ClinicalTrials.gov