Central Venous Catheter Related Bacteremia, Sepsis Affecting Skin
Conditions
Brief summary
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated.
Detailed description
A multicentre, open-label clinical trial of two groups comparing cutaneous asepsis with chlorhexidine gluconate at 2% + isopropyl alcohol 70% in relation to the placement of central venous catheters (Study group) with standard asepsis with aqueous chlorhexidine at 2% (Group Control). The incidence of catheter related bacteremia, the incidence of colonization of the skin and the incidence of colonization of the central venous catheter will be evaluated. The patients will assigned to the treatment group depending on where and when they are treated (site A or site B) and will continue the treatment until the end (continuous design): the patients of Site A will receive the first treatment option and those of Site B will receive the second treatment option during the first 6 months. After this, a rest period of 1 month will be established, during which patients will not be recruited and any of the two cutaneous aseptic methods will be used indiscriminately, in the opinion of the responsible nursing staff. After the resting period, the treatments will be reversed during the following 6 months.
Interventions
DRUGA (Chloraprep)
Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
DRUGB (Clorhexidine 2%)
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will receive one or the other treatment depending on where and when they are treated and will continue the treatment until the end.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients admitted to the ICU. * Patients with age greater than or equal to 18 years. * Patients who require at least one central venous catheters during 48h or more. * Obtaining informed consent.
Exclusion criteria
* Intolerance or known allergy to chlorhexidine, isopropyl alcohol or orange yellow S (E110). * High probability of death within 48 hours after admission. * Use of coated catheter. * Previously included in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of catheter-related bacteremia | Up to 48 hours after discharge from the ICU. | Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl gluconate 70% on the incidence of catheter-related bacteremia in the critical patient with respect to the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pericatheter skin colonization | Through study completion, an average of 1 year | Measure the effect that cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% has on the incidence of pericatheter skin colonization with respect to the control group. Measure with a microbiological culture from the skin area |
| Incidence of colonization of the central venous catheter | Through study completion, an average of 1 year | Measure the effect of cutaneous asepsis with chlorhexidine gluconate 2% + isopropyl 70% on the incidence of colonization of the central venous catheter with respect to the control group. Culture of the tip of the removed catheter. |
Outcome results
None listed