Chlorhexidine containing IV-catheter securement dressings for the prevention of central venous catheter-related bloodstream infections in neutropenic patients: a prospective randomized trial

Not Applicable

• Conditions: T82.7; A41; Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts; Other sepsis

• Registration Number: DRKS00003368
• Lead Sponsor: 1st Department of Internal MedicineCologne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-16
• Study Completion: 2014-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 630

Inclusion Criteria

•Patients receiving a central venous catheter for chemotherapy of:
o AML
o ALL

•Patients receiving receiving a central venous catheter for:
o high-dose chemotherapy with consecutive autologous stem cell transplantation
o any other other condition with an expected duration of chemotherapy-associated neutropenia of at least 5 days and an expected duration of central venous catheter use of at least 10 days

•Age =18 years

Exclusion Criteria

•Patients previously enrolled in the study

•Tunneled central venous catheters

•Shaldon catheters

•CVC insertion via the V. femoralis

•Fever (T >37.8°C) related to a suspected or confirmed bacterial infection at randomization

•Known allergic/hypersensitivity reaction to any compounds of the treatment

•Pregnant or breast-feeding

•Legal incapacity or limited legal capacity

•Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of central venous catheter-related blood stream infections during the first 14 days after placement of the CVC. The endpoint will be documented on the basis of blood culture results and clinical symptoms.<br><br>The following analysis will be adduct to approve a definite blood stream infection:<br><br>Pathogen detected at the catheter tip (by the maki's roll plate nmethod) plus same pathogen with the same susceptibility pattern detected in blood culture,<br><br>Differential time to positivity >2 hours,<br><br>Pathogen detected in quantitative catheter and peripheral blood cultures with a catheter colonie forming unit (CFU) to peripheral CFU ration >=10<br><br><br>

Secondary Outcome Measures

Name	Time	Method
•Incidence of CRBSI-related severe sepsis during the first 14 days after placement of the CVC<br><br>•CRBSI-related mortality during the first 14 days after placement of the CVC<br><br>•Overall CRBSI<br><br>•Overall CRBSI-related severe sepsis<br><br>•Overall CRBSI-related mortality<br><br>•Duration of hospitalization<br><br>•Time to removal of CVC<br><br>•Time to central venous catheter-related blood stream infections<br><br>•Time to first neutropenic fever<br><br>•Rate of unplanned changes<br><br>•Tolerability<br>