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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000008725 |
Receipt No. | R000009983 |
Scientific Title | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. |
Date of disclosure of the study information | 2012/09/01 |
Last modified on | 2014/08/26 |
Basic information | ||
Public title | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. | |
Acronym | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. | |
Scientific Title | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. | |
Scientific Title:Acronym | Examination of the validity of alcoholic chlorhexidine gluconate to prevention of intravascular catheter colonization in an Intensive Care Unit for Adult Patients. | |
Region |
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Condition | |||||
Condition | Intravascular catheter colonization. | ||||
Classification by specialty |
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Classification by malignancy | Others | ||||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the effectiveness for prevention of central venous and arterial catheter colonization of 3 skin antisepsis: 10% aqueous povidone iodine, 1% alcoholic chlorhexidine gluconate, and 0.5% alcoholic chlorhexidine gluconate. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Rates of catheter colonization per 1000 catheter days. |
Key secondary outcomes |
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 | |
Institution consideration | |
Blocking | YES |
Concealment |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection. | |
Interventions/Control_2 | Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection. | |
Interventions/Control_3 | Patients are randomly assigned to 1 of the 3 skin antisepsis groups(0.5% alcoholic chlorhexidine gluconate, 1% alcoholic chlorhexidine gluconate and 10% aqueous povidone iodine), when central venous catheters and arterial catheters are inserted. The distal tips of catheters are semiquantitatively cultured when the catheters are no longer necessary or if there is a suspicion of catheter-related infection. | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | All consecutive central venous and arterial catheters inserted into patients in the ICU. | |||
Key exclusion criteria | The catheters inserted into patients who were less than 18 years of age.
The catheters removed within less than 72 hour of their insertion. The catheters inserted for long-term total parenteral nutrition or chemotherapy. A patient with the allergy to an antiseptic. The catheters inserted with the use of a guidewire. |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Japanese Red Cross Musashino Hospital | ||||||
Division name | Emergency and Critical Care Medicine | ||||||
Zip code | |||||||
Address | 1-26-1 kyounanchou, musashinoshi, tokyo, Japan | ||||||
TEL | 0422-32-3111 | ||||||
yasudahideto@me.com |
Public contact | |||||||
Name of contact person |
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Organization | Japanese Red Cross Musashino Hospital | ||||||
Division name | Emergency and Critical Care Medicine | ||||||
Zip code | |||||||
Address | 1-26-1 kyounanchou, musashinoshi, tokyo, Japan | ||||||
TEL | 0422-32-3111 | ||||||
Homepage URL | |||||||
yasudahideto@me.com |
Sponsor | |
Institute | Nonprofit Organization Japanese Society of Education for Physicians and Trainees in Intensive Care |
Institute | |
Department |
Funding Source | |
Organization | Yoshida Pharmaceutical
Maruishi Pharmaceutical |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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IRB Contact (For public release) | |
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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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
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Results | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009983 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |