ClearGuard HD™

Antimicrobial Barrier Caps for Hemodialysis Catheters

Clinically proven to reduce the rate of CLABSIs in hemodialysis catheter patientsReduce hemodialysis catheter infections
with clinically proven technology
Catheter infections are frequent, costly, and deadly>

Catheters cause 70% of vascular access-related BSIs and central venous
catheters (CVCs) are used in only 19% of all dialysis procedures in the United States1>

Central line-associated bloodstream infections (CLABSIs) are a leading cause ofhospitalizations and the second leading cause of death in hemodialysis patients1,2>

CLABSIs are very expensive, with an estimated increase in healthcare costs ofapproximately $27,232–$68,983, with an average of $48,108 per infection363%

4Reduce hemodialysis catheter infections by up toThe ClearGuard HD antimicrobial barrier cap is the first and only device for sale designed to kill infection-causing
bacteria inside a hemodialysis catheter hub.* ClearGuard HD features a rod that extends into the hemodialysis catheter
hub. The rod and cap threads are coated with chlorhexidine, a well-known broad-spectrum antimicrobial agent.

Antimicrobial agent remains
in desired region due
to the existing clamps
The ClearGuard HD rod and threads
are coated with chlorhexidine, abroad-spectrum antimicrobial agent*Designed to kill microorganisms, not intended to be used for treatment of existing infections.
Curos is a registered trademark of 3M Company.

>

When the ClearGuard HD cap is inserted into aliquid-filled catheter, chlorhexidine elutes from therod into the catheter lock solution>

The chlorhexidine coating dissolves to kill
microorganisms on the inside and outside ofthe catheter hub>The existing catheter clamp holds the antimicrobial
agent inside the catheter hub between treatments>

ClearGuard HD caps are used in place ofa standard cap or connector>

Designed to meet your needs, ClearGuard HD caps canbe used with heparin, citrate and saline solutions.

Clearguard HD antimicrobial barrier caps have been clinically proven to
reduce CLABSIs in hemodialysis catheter patients
4,5

Multiple large, prospective, cluster-randomized multicenter open-label trials demonstrated a significant reductionin the rate of positive blood cultures (PBCs) and CLABSIs using ClearGuard HD caps versus control groups.

Cluster-Randomized Trial of Devices toPrevent Catheter-Related Bloodstream Infections
1.2

ClearGuard HD Caps vs. Tego™+ Curos™
Brunelli, SM et al. Cluster-randomized trial of devices
to prevent catheter-related bloodstream infection.
J Am Soc Nephrol 2018 Apr; 29(4):1336-1343.

1.07

No. of PBC Episodes / 1,000 CVC-days

1.0

1.03

IRR [95% CI] =0.28 [0.13, 0.59]
P = < 0.001

IRR [95% CI] =0.37 [0.20, 0.68]P = 0.001

63%0.750.77

72%

13-month prospective, cluster-randomized
multicenter open-label trial

0.50>

1,671 patients (826 treatment, 845 control)
accruing ~183,000 CVC days>

40 centers across the US>

Primary endpoint was PBC rate as an indicator of BSI rate

0.6

0.4

0.28
0.2

0.22 0.16

Results: Use of the ClearGuard HD caps for 13 months wasassociated with a 63% lower BSI rate vs. use of Tego + Curos.
When considering the de novo subgroup (new CVCs), use ofClearGuard HD caps was associated with a 72% lower BSI rate.

0.0

Baseline

Full Study(13 mos)

ClearGuard HD

de novo CVC(13 mos)

Tego + Curos

Dialysis Catheter-Related Bloodstream Infections:A Cluster-Randomized Trial of the ClearGuard HD
Antimicrobial Barrier Cap
0.8

No. of PBC Episodes / 1,000 CVC-days>

0.8

IRR [95% CI] =0.44 [0.23, 0.83]
P = 0.01
0.60

0.59

0.56

IRR [95% CI] =0.31 [0.12, 0.79]
P = 0.01
0.72

69%IRR [95% CI] =0.32 [0.12, 0.87]
P = 0.02

ClearGuard HD Caps vs. Standard Dialysis Caps
Hymes, JL et al. Dialysis catheter-related bloodstream infections:
A cluster-randomized trial of the ClearGuard HD antimicrobial barrier cap.
Am J Kidney Dis. 2017; 69(2):220-227.

>

12-month prospective, cluster-randomized, multicenter,
open-label comparative effectiveness trial in hemodialysis
patients with central venous catheters>

2,470 patients (1,245 treatment, 1,225 control)
accruing ~350,000 CVC days>

40 centers across the US>

Primary endpoint was PBC rate as an indicator of BSI rate

68%
0.50

56%
0.4

0.26

0.22
0.16

0.0

BaselineFull Study(12 mos)

ClearGuard HD

Sustained(last 6 mos)Standard CVC Caps

de novo CVC(12 mos)Results: Use of the ClearGuard HD caps for 12 months was associatedwith a 56% lower BSI rate vs. use of standard caps. When considering
sustained use (defined as 6 months of the study), the intervention
vs. control was associated with a 69% lower BSI rate.

ClearGuard HD antimicrobial barrier caps used by leading hospitals and clinics
For years, dialysis staff at hospitals and clinics have focused on
educational initiatives to reduce bloodstream infections inhemodialysis patients with limited impact. ClearGuard HD caps
succeed in reducing infections by killing bacteria where bloodstream
infections start-inside the hemodialysis catheter hub. With over 950
hospitals and over 4,600 outpatient dialysis clinics as customers,
ClearGuard HD caps are becoming an increasingly important part ofhemodialysis infection control best practices.

Recommended in Infusion Therapy Standards of Practice 9th edition: 2024
INS SOP, 27. Vascular Access and Hemodialysis, Section C3, For patients receiving hemodialysis through a CVAD, consider the use of an
antimicrobial barrier cap as a strategy to reduce bloodstream infections. (Practice Recommendations)
INS SOP, 47. Vascular Access Device-Related Infection, Section J, For patients receiving outpatient dialysis through a central venouscatheter, consider the use of an antimicrobial barrier cap as a strategy to reduce bloodstream infection. (Practice Recommendations)

Recommended in NKF’s KDOQI Clinical Practice Guideline for Vascular Access: 20196
21.3 KDOQI considers it reasonable to use an antimicrobial barrier cap to help reduce CRBSI in high-riskpatients or facilities; the choice of connector should be based on clinician’s discretion and best clinicaljudgment. (Expert Opinion)

Special Report published by Global Business Media exclusively features ClearGuard HD
Titled: Reducing Catheter Related Bloodstream Infections in Hemodialysis Patients

Recommended in the UKs NICE National Guidance for hemodialysis catheter-related
bloodstream infections: 2021**

Recommended
in the UKs NICE
Medical Technologies
Guidance[MTG62]https://www.nice.org.uk/guidance/mtg62/

Product Ordering information
Product CodeCase Quantity

CGHD-100100

Product Description
ClearGuard™ HD Caps (1 Red, 1 Blue)

1 Nguyen OB, Shugart A, Lines C, Shah AB, Edwards J, Pollock D, Sievert D, Patel PR. National healthcare safety network (NHSN) dialysis event surveillance report for 2014. Clin J Am Soc Nephrol 12(7), 1139-1146, 2017.
2 United States Renal Data System. 2018 USRDS annual report: Epidemiology of kidney disease in the Unites States. National Institutes of Health, Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2018.
3 Results. Content last reviewed November 2017. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/hai/pfp/haccost2017-results.html
4 Brunelli, SM et al. Cluster-randomized trial of devices to prevent catheter-related bloodstream infection. J Am Soc Nephrol. 2018 Apr,29(4):1336-1343.
5 Hymes, JL et al. Dialysis catheter-related bloodstream infections: a cluster-randomized trial of the ClearGuard HD antimicrobial barrier cap. Am J Kidney Dis. 2017 Feb;69(2)220-227.
6 Lok CE, Huber TS, Lee T, et al; KDOQI Vascular Access Guideline Work Group. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis. 2020;75(4)(suppl 2):S1-S164.

Contact us today to find out how ClearGuard HD can play a large role in yourinfection control practices. Visit www.icumed.com or call 866.488.6088© 2024 ICU Medical, Inc. |P24-4776 |For safe and proper use, refer to the Instructions for Use.

800.824.7890 |

www.icumed.com