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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Recruitment Status : Withdrawn (Administrative issues)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

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE April 5, 2018
Last Update Posted Date June 11, 2020
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Trial for Chloraprep Versus Aqueous Chlorhexidine (2%) for the Prevention of Catheter-related Bacteremia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Sepsis Affecting Skin
  • Central Venous Catheter Related Bacteremia
Intervention  ICMJE
  • 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
  • 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%
Study Arms  ICMJE
  • 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.
    Intervention: Drug: A (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.
    Intervention: Drug: B (Clorhexidine 2%)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 10, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
1480
Estimated Study Completion Date  ICMJE April 1, 2021
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03489512
Other Study ID Numbers  ICMJE CHLORAPREP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Instituto de Investigacion Sanitaria La Fe
Study Sponsor  ICMJE Instituto de Investigacion Sanitaria La Fe
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paula Ramirez Galleymore Hospital La Fe
PRS Account Instituto de Investigacion Sanitaria La Fe
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP