Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia

Central Venous Catheter Related Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03489512
• Other study ID #: CHLORAPREP
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: April 1, 2021

Study information

• Verified date: August 2019
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia
• Central Venous Catheter Related Bacteremia
• Sepsis Affecting Skin

Intervention

Drug:
• A (Chloraprep)
Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
• B (Clorhexidine 2%)
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter-related bacteremia	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.	Up to 48 hours after discharge from the ICU.
Secondary	Incidence of pericatheter skin colonization	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	Through study completion, an average of 1 year
Secondary	Incidence of colonization of the central venous catheter	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.	Through study completion, an average of 1 year