Impact of Disinfectant Caps on Nosocomial CLABSI

April 16, 2026 updated by: BDH-Klinik Hessisch Oldendorf

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hessisch Oldendorf, Lower Saxony, Germany, 31840
        • Institute for Neurehabilitative Resaerch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CLABSI-C
Control cohort before use of desinfection caps
Other: sterile catheter cap
sterile catheter caps which has to be desinficated before using
CLABSI-T
Test cohort with use of desinfection caps
Other: use of desinfection caps
Disinfection caps are pre-disinfected closure caps for central venous catheters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of CLABSI episodes
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BDH-Klinik Hessisch Oldendorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 18, 2026

First Submitted That Met QC Criteria

February 18, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLABSI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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