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

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ClinicalTrials.gov Identifier: NCT03489512
Recruitment Status : Withdrawn (Administrative issues)
First Posted : April 5, 2018
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigacion Sanitaria La Fe

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.

Condition or disease Intervention/treatment Phase
Sepsis Affecting Skin Central Venous Catheter Related Bacteremia Drug: A (Chloraprep) Drug: B (Clorhexidine 2%) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : April 1, 2021


Arm Intervention/treatment
Experimental: A (Chloraprep)
2% chlorhexidine gluconate with 70% isopropyl alcohol with a sterile 3ml single dose applicator. Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change.
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%)
Other Name: Chloraprep

Active Comparator: B (Clorhexidine 2%)
2% aqueous base chlorhexidine (10 ml single dose containers). Use for the preparation of the skin before insertion of the central venous catheters and at each dressing change.
Drug: B (Clorhexidine 2%)
Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
Other Name: Clorhexidine 2%




Primary Outcome Measures :
  1. Incidence of catheter-related bacteremia [ Time Frame: 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 Outcome Measures :
  1. Incidence of pericatheter skin colonization [ Time Frame: 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


  2. Incidence of colonization of the central venous catheter [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489512


Sponsors and Collaborators
Instituto de Investigacion Sanitaria La Fe
Investigators
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Principal Investigator: Paula Ramirez Galleymore Hospital La Fe
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Responsible Party: Instituto de Investigacion Sanitaria La Fe
ClinicalTrials.gov Identifier: NCT03489512    
Other Study ID Numbers: CHLORAPREP
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents