Clinical trial NCT03489512: Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia
Official title: Clinical Phase IV Comparison Trial for 2% Chlorhexidine Skin Asepsis +70% Alcohol Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia in Critical Patients: Preliminary Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Sepsis Affecting Skin
Central Venous Catheter Related Bacteremia
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of catheter-related bacteremia
timeFrame: Up to 48 hours after discharge from the ICU.
Secondary outcomes:
measure: Incidence of pericatheter skin colonization
timeFrame: Through study completion, an average of 1 year
measure: Incidence of colonization of the central venous catheter
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hospital La Fe
name: Paula Ramirez Galleymore
role: PRINCIPAL_INVESTIGATOR
References: