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Impact of Disinfectant Caps on Nosocomial CLABSI

NCT07430215 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

OTHER

use of desinfection caps

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

OTHER

sterile catheter cap

sterile catheter caps which has to be desinficated before using

Sponsors & Collaborators

  • BDH-Klinik Hessisch Oldendorf

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Germany

Study Locations

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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 NCT07430215 on ClinicalTrials.gov