Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial
Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous c...
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| description | Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC).
From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared.
The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4-1.3), compared to 1.19 (95% confidence interval, 0.7-1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27-1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events.
In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients.
ClinicalTrials.gov NCT00122642. |
| doi_str_mv | 10.1371/journal.pone.0010840 |
| format | Article |
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From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared.
The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4-1.3), compared to 1.19 (95% confidence interval, 0.7-1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27-1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events.
In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients.
ClinicalTrials.gov NCT00122642.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0010840</identifier><identifier>PMID: 20520776</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Alcohol ; Analysis ; Antibiotics ; Antimicrobial agents ; Bacteremia ; Bacteremia - etiology ; Bacteremia - prevention & control ; Biofilms ; Care and treatment ; Catheter-Related Infections - etiology ; Catheter-Related Infections - prevention & control ; Catheterization ; Catheters ; Catheters, Indwelling - adverse effects ; Chemotherapy ; Clinical trials ; Complications and side effects ; Confidence intervals ; Disease prevention ; Drug Administration Schedule ; Epidemiology ; Ethanol ; Ethanol - administration & dosage ; Ethanol - adverse effects ; Female ; Hematology ; Hospitals ; Humans ; Hydrochloric acid ; Incidence ; Infection ; Infectious diseases ; Infectious Diseases/Bacterial Infections ; Infectious Diseases/Epidemiology and Control of Infectious Diseases ; Intensive care ; Internal medicine ; Kaplan-Meier Estimate ; Locks ; Male ; Mechanical properties ; Medical instruments ; Medicine ; Microbiology/Applied Microbiology ; Microbiology/Medical Microbiology ; Microorganisms ; Middle Aged ; Morbidity ; Mortality ; Mucositis ; Patients ; Placebos ; Prevention ; Preventive medicine ; Public Health and Epidemiology/Nosocomial and Healthcare-Associated Infections ; Randomization ; Reduction ; Sepsis ; Statistical analysis ; Studies ; Systematic review ; Translocation ; Young Adult</subject><ispartof>PloS one, 2010-05, Vol.5 (5), p.e10840</ispartof><rights>COPYRIGHT 2010 Public Library of Science</rights><rights>2010 Slobbe et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Slobbe et al. 2010</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c723t-490238440c7e9dff61b442f3d4cf170705f87bb7b65135fe6d5356aa15d5102a3</citedby><cites>FETCH-LOGICAL-c723t-490238440c7e9dff61b442f3d4cf170705f87bb7b65135fe6d5356aa15d5102a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2877107/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC2877107/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793,79600,79601</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20520776$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Gold, Jeffrey A.</contributor><creatorcontrib>Slobbe, Lennert</creatorcontrib><creatorcontrib>Doorduijn, Jeanette K</creatorcontrib><creatorcontrib>Lugtenburg, Pieternella J</creatorcontrib><creatorcontrib>El Barzouhi, Abdelilah</creatorcontrib><creatorcontrib>Boersma, Eric</creatorcontrib><creatorcontrib>van Leeuwen, Willem B</creatorcontrib><creatorcontrib>Rijnders, Bart J A</creatorcontrib><title>Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC).
From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared.
The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4-1.3), compared to 1.19 (95% confidence interval, 0.7-1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27-1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events.
In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients.
ClinicalTrials.gov NCT00122642.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Alcohol</subject><subject>Analysis</subject><subject>Antibiotics</subject><subject>Antimicrobial agents</subject><subject>Bacteremia</subject><subject>Bacteremia - etiology</subject><subject>Bacteremia - prevention & control</subject><subject>Biofilms</subject><subject>Care and treatment</subject><subject>Catheter-Related Infections - etiology</subject><subject>Catheter-Related Infections - prevention & control</subject><subject>Catheterization</subject><subject>Catheters</subject><subject>Catheters, Indwelling - adverse effects</subject><subject>Chemotherapy</subject><subject>Clinical trials</subject><subject>Complications and side effects</subject><subject>Confidence intervals</subject><subject>Disease prevention</subject><subject>Drug Administration Schedule</subject><subject>Epidemiology</subject><subject>Ethanol</subject><subject>Ethanol - administration & dosage</subject><subject>Ethanol - adverse effects</subject><subject>Female</subject><subject>Hematology</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Hydrochloric acid</subject><subject>Incidence</subject><subject>Infection</subject><subject>Infectious diseases</subject><subject>Infectious Diseases/Bacterial Infections</subject><subject>Infectious Diseases/Epidemiology and Control of Infectious Diseases</subject><subject>Intensive care</subject><subject>Internal medicine</subject><subject>Kaplan-Meier Estimate</subject><subject>Locks</subject><subject>Male</subject><subject>Mechanical properties</subject><subject>Medical instruments</subject><subject>Medicine</subject><subject>Microbiology/Applied Microbiology</subject><subject>Microbiology/Medical Microbiology</subject><subject>Microorganisms</subject><subject>Middle Aged</subject><subject>Morbidity</subject><subject>Mortality</subject><subject>Mucositis</subject><subject>Patients</subject><subject>Placebos</subject><subject>Prevention</subject><subject>Preventive medicine</subject><subject>Public Health and Epidemiology/Nosocomial and Healthcare-Associated Infections</subject><subject>Randomization</subject><subject>Reduction</subject><subject>Sepsis</subject><subject>Statistical analysis</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Translocation</subject><subject>Young 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and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Slobbe, Lennert</au><au>Doorduijn, Jeanette K</au><au>Lugtenburg, Pieternella J</au><au>El Barzouhi, Abdelilah</au><au>Boersma, Eric</au><au>van Leeuwen, Willem B</au><au>Rijnders, Bart J A</au><au>Gold, Jeffrey A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2010-05-26</date><risdate>2010</risdate><volume>5</volume><issue>5</issue><spage>e10840</spage><pages>e10840-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Catheter-related bloodstream infection (CRBSI) results in significant attributable morbidity and mortality. In this randomized, double-blind, placebo-controlled trial, we studied the efficacy and safety of a daily ethanol lock for the prevention of CRBSI in patients with a tunnelled central venous catheter (CVC).
From 2005 through 2008, each lumen of the CVC of adult hematology patients was locked for 15 minutes per day with either 70%-ethanol or placebo, where after the lock solution was flushed through. As a primary endpoint, the incidence rates of endoluminal CRBSI were compared.
The intent-to-treat analysis was based on 376 patients, accounting for 448 CVCs and 27,745 catheter days. For ethanol locks, the incidence of endoluminal CRBSI per 1000 CVC-days was 0.70 (95%-CI, 0.4-1.3), compared to 1.19 (95% confidence interval, 0.7-1.9) for placebo (incidence rate-ratio, 0.59; 95% confidence interval, 0.27-1.30; P = .19). For endoluminal CRBSI according to the strictest definition (positive hub culture and identical bacterial strain in blood), a 3.6-fold, non-significant, reduction was observed for patients receiving ethanol (2 of 226 versus 7 of 222; P = .103). No life-threatening adverse events were observed. More patients receiving ethanol discontinued lock-therapy (11 of 226 versus 1 of 222; P = .006) or continued with decreased lock-frequency (10 of 226 versus 0 of 222; P = .002), due to non-severe adverse events.
In this study, the reduction in the incidence of endoluminal CRBSI using preventive ethanol locks was non-significant, although the low incidence of endoluminal CRBSI precludes definite conclusions. Therefore, the lack of statistical significance may partially reflect a lack of power. Significantly more patients treated with ethanol locks discontinued their prophylactic treatment due to adverse effects, which were non-severe but reasonably ethanol related. Additional studies should be performed in populations with higher incidence of (endoluminal) CRBSI. Alternative sources of bacteremia, like exoluminal CRBSI or microbial translocation during chemotherapy-induced mucositis may have been more important in our patients.
ClinicalTrials.gov NCT00122642.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>20520776</pmid><doi>10.1371/journal.pone.0010840</doi><tpages>e10840</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2010-05, Vol.5 (5), p.e10840 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1292619838 |
| source | MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Public Library of Science (PLoS); PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adolescent Adult Aged Aged, 80 and over Alcohol Analysis Antibiotics Antimicrobial agents Bacteremia Bacteremia - etiology Bacteremia - prevention & control Biofilms Care and treatment Catheter-Related Infections - etiology Catheter-Related Infections - prevention & control Catheterization Catheters Catheters, Indwelling - adverse effects Chemotherapy Clinical trials Complications and side effects Confidence intervals Disease prevention Drug Administration Schedule Epidemiology Ethanol Ethanol - administration & dosage Ethanol - adverse effects Female Hematology Hospitals Humans Hydrochloric acid Incidence Infection Infectious diseases Infectious Diseases/Bacterial Infections Infectious Diseases/Epidemiology and Control of Infectious Diseases Intensive care Internal medicine Kaplan-Meier Estimate Locks Male Mechanical properties Medical instruments Medicine Microbiology/Applied Microbiology Microbiology/Medical Microbiology Microorganisms Middle Aged Morbidity Mortality Mucositis Patients Placebos Prevention Preventive medicine Public Health and Epidemiology/Nosocomial and Healthcare-Associated Infections Randomization Reduction Sepsis Statistical analysis Studies Systematic review Translocation Young Adult |
| title | Prevention of catheter-related bacteremia with a daily ethanol lock in patients with tunnelled catheters: a randomized, placebo-controlled trial |
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