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Not Yet RecruitingNCT07430215

Impact of Disinfectant Caps on Nosocomial CLABSI

Incidence of Nosocomial, Catheter-associated Bloodstream Infections Depending on the Use of Disinfectant Caps

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
BDH-Klinik Hessisch Oldendorf · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERuse of desinfection capsDisinfection caps are pre-disinfected closure caps for central venous catheters.
OTHERsterile catheter capsterile catheter caps which has to be desinficated before using

Timeline

Start date
2026-03-01
Primary completion
2027-09-30
Completion
2027-12-31
First posted
2026-02-24
Last updated
2026-02-25

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT07430215. Inclusion in this directory is not an endorsement.