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Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial


N/A
18 Years
N/A
Open (Enrolling)
Both
Catheter-related Bloodstream Infection

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Trial Information

Chlorhexidine Containing Iv-securement Dressings for the Prevention of Central Venous Catheter-related Blood Stream Infections in Neutropenic Patients: a Randomized Trial


Inclusion Criteria:



- Patients receiving a central venous catheter for chemotherapy of AML or ALL

- Patients receiving a central venous catheter for high-dose chemotherapy with
consecutive autologous stem cell transplantation or any 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:

- Condition with an expected duration of chemotherapy-associated neutropenia of at less
than 5 days and an expected duration of central venous catheter use of less than 10
days

- Use of a central venous catheter with antimicrobial coating other than chlorhexidine
and/or silver-sulfadiazine

- Limited venous status, impeding acquisition of peripheral blood cultures in case of
febrile neutropenia

- 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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

Outcome Description:

Incidence of definite catheter-related bloodstream infection during the first 14 days after placement of the central venous catheter

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Maria JG Vehreschild, Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DRKS00003368

NCT ID:

NCT01544686

Start Date:

February 2012

Completion Date:

May 2014

Related Keywords:

  • Catheter-related Bloodstream Infection
  • neutropenia
  • cancer
  • fever
  • central venous catheter
  • infection

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