UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001400 |
|---|---|
| Receipt number | R000001701 |
| Scientific Title | Comparison of maximal sterile barrier precautions with standard sterile barrier precautions on catheter-related blood stream infection: a multi-institutional randomized controlled trial. |
| Date of disclosure of the study information | 2008/09/27 |
| Last modified on | 2015/04/06 12:28:59 |
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Basic information
Public title
Comparison of maximal sterile barrier precautions with standard sterile barrier precautions on catheter-related blood stream infection: a multi-institutional randomized controlled trial.
Acronym
maximal precaution trial
Scientific Title
Comparison of maximal sterile barrier precautions with standard sterile barrier precautions on catheter-related blood stream infection: a multi-institutional randomized controlled trial.
Scientific Title:Acronym
maximal precaution trial
Region
| Japan |
Condition
Condition
Patients who were admitted in the general surgical wards and were planned to be inserted non-tunneled CVC.
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether institution of maximal sterile barrier precautions (MSBP) during central venous catheter (CVC) insertion prevents catheter-related blood stream infection comparing to standard sterile barrier precautions (SSBP) in the surgical wards
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
catheter-related blood stream infection (CRBSI)
Key secondary outcomes
catheter-related infection (CRI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
maximal sterile barrier precautions (MSBP)
Interventions/Control_2
standard sterile barrier precautions (SSBP)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted into the general surgical wards and were planed to be inserted a non-tunnel type CVC.
Key exclusion criteria
(1) Patients under 18 years old
(2) Patients who had a temparature 0f 38.1 degree centigrade or above.
(3) Patients who had already been administered antibiotics before CVC insertion.
(4) Patients who were inserted CVC as a replacement.
(5) Patients who were in the ICU.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Haga |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Department of Surgery
Zip code
Address
1-5Ninomaru, Kumamoto, Japan
TEL
096-353-6501
yoshio@kumamed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Haga |
Organization
National Hospital Organization Kumamoto Medical Center
Division name
Department of Surgery
Zip code
Address
1-5Ninomaru, Kumamoto, Japan
TEL
096-353-6501
Homepage URL
yoshio@kumamed.jp
Sponsor or person
Institute
National Hospital Organization Kumamoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Health Science Research Grants for Research on Medical Technology Assessment and Comprehensive Research on Aging and Health, from the Ministry of Health, Labour, and Welfare of Japan.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/annalsofsurgery/Abstract/2010/04000/Maximal_Sterile_Barrier_Precautions_Do_Not_Reduce.7.aspx
Number of participants that the trial has enrolled
Results
424 patients scheduled for CVC insertion in surgical units at nine medical centers in Japan were randomly assigned to either an MSBP group (n=211) or a standard sterile barrier precaution (SSBP) group (n=213). The median (range) duration of catheterization was 14 days (0 to 92 days) in the MSBP group and 14 days (0 to 112 days) in the SSBP group. There were 5 cases (2.4%) of CRBSI in the MSBP group and 6 cases (2.8%) in the SSBP group (relative risk [RR], 0.84; 95% confidence interval [CI], 0.26 to 2.7; P=0.77). The rate of CRBSIs per 1000 catheter days was 1.5 in the MSBP group and 1.6 in the SSBP group. There were 8 cases (3.8%) of catheter-related infections (CRIs) in the MSBP group and 7 cases (3.3%) in the SSBP group (RR, 1.2; 95%CI, 0.43 to 3.1; P=0.78). The rate of CRI per 1000 catheter days was 2.4 in the MSBP group and 1.9 in the SSBP group. This study is larger in sample size than the one performed by Raad et al and could not demonstrate better prevention of CRBSIs by MSBP compared with SSBP. A large RCT or at least a meta-analysis of any other studies in the literature is necessary to reach a conclusion on this issue.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
This study was reported in Annals of Surgery.
Ann Surg, 2010;251(4): 620–623.
Management information
Registered date
| 2008 | Year | 09 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001701
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
