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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037492 |
Receipt No. | R000042719 |
Scientific Title | Effect of prophylaxis using 1% chlorhexidine gluconate and chlorhexidine-gel-impregnated dressings on central venous catheter-related thrombosis and infections in critically ill patients: a retrospective observational study. |
Date of disclosure of the study information | 2019/07/25 |
Last modified on | 2019/07/25 |
Basic information | ||
Public title | Study using chlorhexidine on catheter related thrombosis and infections. | |
Acronym | Study using chlorhexidine on catheter related thrombosis and infections. | |
Scientific Title | Effect of prophylaxis using 1% chlorhexidine gluconate and chlorhexidine-gel-impregnated dressings on central venous catheter-related thrombosis and infections in critically ill patients: a retrospective observational study. | |
Scientific Title:Acronym | Study using chlorhexidine on catheter related thrombosis and infections. | |
Region |
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Condition | ||
Condition | Patients who required central venous catheter for more than 48 hours in intensive care unit | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study aimed to determine the prophylactic effect of a 1% alcoholic chlorhexidine gluconate and chlorhexidine-gel-impregnated dressing combination on catheter-related thrombosis, which is a known risk factor for catheter-related bloodstream infections, in critically ill patients. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Catheter-related thrombosis within 14 days of catheter insertion |
Key secondary outcomes |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | We included patients who required central venous catheter (CVC) for more than 48 hours in the intensive care unit(ICU). Patients whose CVCs were inserted in the ICU or operating room were included. Catheters inserted via the internal jugular vein were included. 12-gauge triple lumina CVCs were used. | |||
Key exclusion criteria | We excluded patients who were inserted in places outside the intensive care unit (ICU) or operating room, or whose catheters inserted via the subclavian or femoral veins, or who were less than 48 hours in ICU, or who had a history of hypersensitivity for chlorhexidine. | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Saga University Hospital | ||||||
Division name | Intensive Care Unit | ||||||
Zip code | 849-8501 | ||||||
Address | 5-1-1, Nabeshima, Saga City, Saga, Japan. | ||||||
TEL | 0952-34-2324 | ||||||
yamadato@cc.saga-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Saga University Hospital | ||||||
Division name | Intensive Care Unit | ||||||
Zip code | 849-8501 | ||||||
Address | 5-1-1, Nabeshima, Saga City, Saga, Japan. | ||||||
TEL | 0952-34-2324 | ||||||
Homepage URL | |||||||
yamadato@cc.saga-u.ac.jp |
Sponsor | |
Institute | Intensive Care Unit, Saga University Hospital |
Institute | |
Department |
Funding Source | |
Organization | Department of Anesthesiology and Critical Care Medicine, Faculty of Medicine, Saga University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Clinical Research Center, Saga University Hospital |
Address | 5-1-1, Nabeshima, Saga City, Saga, Japan. |
Tel | 0952-34-3400 |
kenkyu-shinsei@ml.cc.saga-u.ac.jp |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 134 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Other | |
Other related information | We included all patients who matched the inclusion criteria, who managed in the intensive care unit between November 2009-December 2010 and September 2012-December 2014, in this study. |
Management information | |||||||
Registered date |
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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=R000042719 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |