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

NCT03309137 | Completed

• 1 other identifier: 3654
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood stream infections; Prospective; Preventative; Randomized

Outcome Measures

Primary Outcomes (1)

• Compliance with the protocol

  The investigators will consider our study successful if we achieve compliance of than 90% use of device for locking.

  Through study completion, an average of 14 days

Secondary Outcomes (2)

• Bacteremia

  Through study completion, an average of 14 days

• Bacteria colonization of central line

  Through study completion, an average of 14 days

Study Arms (2)

Antiseptic device

EXPERIMENTAL

Patients who are randomized to receive the device will receive Chlorhexidine at a dose of 0.24-0.42 mg/installation into all intravenous lines. The intervention will be administered every 24 hrs and as needed for as long as the intravenous is in place

Device: Chlorhexidine flush

Routine Care

NO INTERVENTION

Patients who are randomized to routine care (no device, no intervention) will receive normal saline flush as per standard ICU care.

Interventions

Chlorhexidine flush DEVICE

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.

Also known as: CHG-Lock™

Antiseptic device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old adult patients admitted to the ICU;
• Same-day admit to ICU;
• Post-op patient with central lines in situ (PICC, multi-lumen, side arm of introducer catheters or temporary dialysis lines), AND;
• Expected to have at least 1 central line in situ for more than 72 hrs.

You may not qualify if:

• \>24hrs post-admittance to ICU
• Hopeless prognosis
• Currently admitted with known infection or suspicion of infection (i.e. known endocarditis or other infections).
• Chronic indwelling central venous catheters present
• Patients with known allergies to chlorhexidine

Sponsors & Collaborators

• Alison Fox-Robichaud: lead
• Dr. Richard Whitlock: collaborator
• Dr. Julian Owen: collaborator
• Pamela Benoit, RN: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (5)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 RESULT

• Holton D, Paton S, Conly J, Embree J, Taylor G, Thompson W. Central venous catheter-associated bloodstream infections occurring in Canadian intensive care units: A six-month cohort study. Can J Infect Dis Med Microbiol. 2006 May;17(3):169-76. doi: 10.1155/2006/781735.

  PMID: 18418495 RESULT

• Ziegler MJ, Pellegrini DC, Safdar N. Attributable mortality of central line associated bloodstream infection: systematic review and meta-analysis. Infection. 2015 Feb;43(1):29-36. doi: 10.1007/s15010-014-0689-y. Epub 2014 Oct 21.

  PMID: 25331552 RESULT

• Pook M, Zamir N, McDonald E, Fox-Robichaud A. Chlorhexidine (di)gluconate locking device for central line infection prevention in intensive care unit patients: a multi-unit, pilot randomized controlled trial. Br J Nurs. 2022 Jul 21;31(14):S36-S46. doi: 10.12968/bjon.2022.31.14.S36.

  PMID: 35856588 DERIVED

• Zamir N, Pook M, McDonald E, Fox-Robichaud AE. Chlorhexidine locking device for central line infection prevention in ICU patients: protocol for an open-label pilot and feasibility randomized controlled trial. Pilot Feasibility Stud. 2020 Feb 18;6:26. doi: 10.1186/s40814-020-0564-9. eCollection 2020.

  PMID: 32099661 DERIVED

MeSH Terms

Conditions

Infections; Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alison Fox-Robichaud, MD

  Hamilton Health Sciences Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor McMaster University and Director of Medical Education at HHS

Model Details: An Open Label Randomized Feasibility Pilot Study

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 13, 2017
• Study Start: November 19, 2017
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)