Impact of Disinfectant Caps on Nosocomial CLABSI

NCT07430215 | Active Not Recruiting

• 1 other identifier: CLABSI
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In a worldwide, one-day, prospective point-prevalence study, a prevalence of 15.1% for hospital-acquired central line-associated bloodstream infections (HA-CLABSI) was determined in 13,796 patients across 1,265 intensive care units in 75 countries. According to reference data from the National Reference Center for Surveillance of Nosocomial Infections, an average of 1.2 HA-CLABSI episodes per 1,000 central venous catheter days occurred in German intensive care units between 2020 and 2024. Since the mean length of stay for the observed patients was 4 days, this value could be significantly higher for patients with longer stays, such as those undergoing neurological rehabilitation. Besides economic consequences (costs of CLABSI treatment, extended treatment duration), bloodstream infections also have a significant impact on treatment outcomes. Studies show that patients have twice the mortality risk after a bloodstream infection - even after adjusting for disease severity - and that bloodstream infections are associated with longer stays in the intensive care unit and in the hospital. Bloodstream infections occur when pathogenic germs enter the bloodstream. This can happen through entry via wounds (e.g., after trauma), via venous catheters (catheter-associated), or through other infections that spread systemically (e.g., infections in the lungs, abdomen, or urinary tract). To reduce the risk of pathogenic germs entering the bloodstream from venous catheters via the access point, disinfection caps can be used. These caps are pre-treated with 70% isopropanol and packaged sterilely. According to an observational study, the use of such disinfection caps in an oncology clinic significantly reduced the rate of contaminated blood cultures (central venous catheters) from 2.5% (17 of 692) to 0.2% (1 of 470). To reduce the risk of pathogenic germs entering the bloodstream from venous catheters, disinfection caps can be used. As part of quality-improvement measures, the use of disinfectant caps is planned in the neurological intensive care unit. The use of these caps therefore does not constitute a study intervention in the strict sense, but rather the implementation of a new in-house quality standard.

Conditions

Central Line-associated Bloodstream Infections

Keywords

central lien catheter; bloodstream infection; intensive care

Outcome Measures

Primary Outcomes (1)

• Incidence of CLABSI episodes

  1 year

Study Arms (2)

CLABSI-C

Control cohort before use of desinfection caps

Other: sterile catheter cap

CLABSI-T

Test cohort with use of desinfection caps

Other: use of desinfection caps

Interventions

use of desinfection caps OTHER

Disinfection caps are pre-disinfected closure caps for central venous catheters.

CLABSI-T

sterile catheter cap OTHER

sterile catheter caps which has to be desinficated before using

CLABSI-C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient admissions to the neurological intensive care unit within one year are prospectively recruited from the patient population of the BDH Clinic in Hessisch Oldendorf. Recruitment is carried out through continuous screening of all newly admitted patients who meet the inclusion criteria. In addition, retrospective data collection is performed. Only patient data whose relatives have consented to the processing of routine data for quality assurance and research purposes are analyzed.

You may qualify if:

• Stay in the neurological intensive care unit
• Presence of a central venous catheter (CVC)
• Written consent from the legal representative of the study participant (if the participant lacks capacity to consent) and/or from the study participant (if the participant is capable of consenting) for the use of routine data for quality and research purposes

You may not qualify if:

• written objection to the use of routine data for quality and research purposes

Sponsors & Collaborators

• BDH-Klinik Hessisch Oldendorf: lead

Study Sites (1)

Institute for Neurehabilitative Resaerch

Hessisch Oldendorf, Lower Saxony, 31840, Germany

Location

Related Publications (6)

• Nationales Referenzzentrum für Surveillance von nosokomialen Infektionen (NRZ) (Hrsg) (2025) KISS Krankenhaus-Infektions-Surveillance-System. Infektionssurveillance im Modul ITS-KISS. Referenzdaten. Berechnungszeitraum: Januar 2020 bis Dezember 2024

  BACKGROUND

• Sweet MA, Cumpston A, Briggs F, Craig M, Hamadani M. Impact of alcohol-impregnated port protectors and needleless neutral pressure connectors on central line-associated bloodstream infections and contamination of blood cultures in an inpatient oncology unit. Am J Infect Control. 2012 Dec;40(10):931-4. doi: 10.1016/j.ajic.2012.01.025. Epub 2012 May 9.

  PMID: 22575286 BACKGROUND

• 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 BACKGROUND

• Shannon RP, Patel B, Cummins D, Shannon AH, Ganguli G, Lu Y. Economics of central line--associated bloodstream infections. Am J Med Qual. 2006 Nov-Dec;21(6 Suppl):7S-16S. doi: 10.1177/1062860606294631.

  PMID: 17077414 BACKGROUND

• Warren DK, Quadir WW, Hollenbeak CS, Elward AM, Cox MJ, Fraser VJ. Attributable cost of catheter-associated bloodstream infections among intensive care patients in a nonteaching hospital. Crit Care Med. 2006 Aug;34(8):2084-9. doi: 10.1097/01.CCM.0000227648.15804.2D.

  PMID: 16763511 BACKGROUND

• Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, Moreno R, Lipman J, Gomersall C, Sakr Y, Reinhart K; EPIC II Group of Investigators. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009 Dec 2;302(21):2323-9. doi: 10.1001/jama.2009.1754.

  PMID: 19952319 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 24, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)