<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03253887</url>
  </required_header>
  <id_info>
    <org_study_id>55008116.8.0000.5201</org_study_id>
    <nct_id>NCT03253887</nct_id>
  </id_info>
  <brief_title>Ethanol-lock Therapy for the Prevention of Non-tunneled Catheter-related Infection in Pediatric Patients</brief_title>
  <acronym>E-LockPed</acronym>
  <official_title>Effectiveness of Ethanol-Lock Therapy for the Prevention of Non-Tunneled Catheter-Related Bloodstream Infection in Pediatric Patients: A Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Materno Infantil Prof. Fernando Figueira</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bellisa Caldas Lopes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thuanne Beatriz Silva Tenório</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rodrigo Melo Gallindo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paulo Sérgio Gomes Nogueira Borges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lara Barreto Machado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Materno Infantil Prof. Fernando Figueira</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Central venous catheter (CVC) infection is a common complication in pediatric patients,&#xD;
      resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures&#xD;
      and increase morbidity and mortality. Given the repercussion of this complication, measures&#xD;
      that minimize its should be stimulated. The purpose of this study is to evaluate the effects&#xD;
      of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of&#xD;
      short-term central venous catheters in pediatric patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients was divided into two groups, where one received alcoholization (ethanol lock&#xD;
      therapy group) and the other not (control group). The variables evaluated were: CLABSI,&#xD;
      etiological agents, adverse events and the mechanical effects of ethanol on the catheter&#xD;
      (breakage and obstruction). To determine the association between the independent variable and&#xD;
      the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test&#xD;
      were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95%&#xD;
      confidence interval (95% CI). The significance level of 5% was adopted. The sample size&#xD;
      calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter&#xD;
      clinical trial was used to calculate the sample size, which demonstrated a 9% central venous&#xD;
      catheter infection frequency in the ethanol group and 37% in the control group, so that the&#xD;
      sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of&#xD;
      5% and 10% of post-randomization losses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>It's a randomized controlled clinical trial.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Following inclusion, the patients were randomized into two groups, the ethanol-lock group and the control group, using allocation concealment with a list of random numbers generated using the Random Allocation Software</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them</measure>
    <time_frame>Period from 48 hours after catheter insertion to 24 hours after catheter removal</time_frame>
    <description>Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>main etiological agents involved in central line associated bloodstream infection (CLABSI) events</measure>
    <time_frame>Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.</time_frame>
    <description>The organisms responsable for each CLABSI event: gram negatives, gram positives or fungus. Identified by one or more blood specimens by a culture or non-culture based microbiologic testing method and the organism(s) identified in blood is not related to an infection at another site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>During the use of ethanol-lock therapy</time_frame>
    <description>Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)</measure>
    <time_frame>During the use of ethanol-lock therapy</time_frame>
    <description>Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Infection, Catheter-Related</condition>
  <condition>Central Line-associated Bloodstream Infection (CLABSI)</condition>
  <condition>Pediatric</condition>
  <arm_group>
    <arm_group_label>Ethanol-lock therapy (ELT) Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ethanol-lock</intervention_name>
    <description>This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution.</description>
    <arm_group_label>Ethanol-lock therapy (ELT) Group</arm_group_label>
    <other_name>Ethanol 70%</other_name>
    <other_name>Alcohol 70%</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pediatric surgery patients;&#xD;
&#xD;
          -  Weight: 2 Kg or more;&#xD;
&#xD;
          -  Using non-tunneled double-lumen polyurethane central venous catheter;&#xD;
&#xD;
          -  CVC inserted at operation room, Pediatric Intensive Care Unit (PICU) or Neonatal&#xD;
             Intensive Care Unit (NICU);&#xD;
&#xD;
          -  CVC adequately positioned (checked by radioscopy ou radiography);&#xD;
&#xD;
          -  CVC implanted within a maximum of 24 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose catheters had been inserted under emergency situations;&#xD;
&#xD;
          -  Patients in a critical condition (those requiring continuous fluid/drug infusion&#xD;
             through both lumens);&#xD;
&#xD;
          -  Patients with a history of hypersensitivity or allergic reactions to ethanol were&#xD;
             excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bellisa C Lopes, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto de Medicina Integral Prof Fernando Figueira</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto de Medicina Integral Prof Fernando Figueira</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50070-550</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Flynn PM. Diagnosis and management of central venous catheter-related bloodstream infections in pediatric patients. Pediatr Infect Dis J. 2009 Nov;28(11):1016-7. doi: 10.1097/INF.0b013e3181bf7bfc. No abstract available.</citation>
    <PMID>19859018</PMID>
  </reference>
  <reference>
    <citation>Ullman AJ, Cooke ML, Mitchell M, Lin F, New K, Long DA, Mihala G, Rickard CM. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015 Sep 10;2015(9):CD010367. doi: 10.1002/14651858.CD010367.pub2.</citation>
    <PMID>26358142</PMID>
  </reference>
  <reference>
    <citation>Rosado V, Romanelli RM, Camargos PA. Risk factors and preventive measures for catheter-related bloodstream infections. J Pediatr (Rio J). 2011 Nov-Dec;87(6):469-77. doi: 10.2223/JPED.2134.</citation>
    <PMID>22170387</PMID>
  </reference>
  <reference>
    <citation>Subha Rao SD, Joseph MP, Lavi R, Macaden R. Infections related to vascular catheters in a pediatric intensive care unit. Indian Pediatr. 2005 Jul;42(7):667-72.</citation>
    <PMID>16085967</PMID>
  </reference>
  <reference>
    <citation>Cruzeiro PC, Camargos PA, Miranda ME. Central venous catheter placement in children: a prospective study of complications in a Brazilian public hospital. Pediatr Surg Int. 2006 Jun;22(6):536-40. doi: 10.1007/s00383-006-1671-2. Epub 2006 May 5.</citation>
    <PMID>16736225</PMID>
  </reference>
  <reference>
    <citation>Huang EY, Chen C, Abdullah F, Aspelund G, Barnhart DC, Calkins CM, Cowles RA, Downard CD, Goldin AB, Lee SL, St Peter SD, Arca MJ; 2011 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Strategies for the prevention of central venous catheter infections: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2011 Oct;46(10):2000-11. doi: 10.1016/j.jpedsurg.2011.06.017.</citation>
    <PMID>22008341</PMID>
  </reference>
  <reference>
    <citation>Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. WITHDRAWN: Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev. 2016 May 4;(5):CD003827. doi: 10.1002/14651858.CD003827.pub3. No abstract available.</citation>
    <PMID>27144903</PMID>
  </reference>
  <reference>
    <citation>Costello JM, Morrow DF, Graham DA, Potter-Bynoe G, Sandora TJ, Laussen PC. Systematic intervention to reduce central line-associated bloodstream infection rates in a pediatric cardiac intensive care unit. Pediatrics. 2008 May;121(5):915-23. doi: 10.1542/peds.2007-1577.</citation>
    <PMID>18450894</PMID>
  </reference>
  <reference>
    <citation>Wolf J, Shenep JL, Clifford V, Curtis N, Flynn PM. Ethanol lock therapy in pediatric hematology and oncology. Pediatr Blood Cancer. 2013 Jan;60(1):18-25. doi: 10.1002/pbc.24249. Epub 2012 Aug 21.</citation>
    <PMID>22911535</PMID>
  </reference>
  <reference>
    <citation>Shenep LE, Shenep MA, Cheatham W, Hoffman JM, Hale A, Williams BF, Perkins R, Hewitt CB, Hayden RT, Shenep JL. Efficacy of intravascular catheter lock solutions containing preservatives in the prevention of microbial colonization. J Hosp Infect. 2011 Dec;79(4):317-22. doi: 10.1016/j.jhin.2011.07.010. Epub 2011 Sep 25.</citation>
    <PMID>21945067</PMID>
  </reference>
  <reference>
    <citation>Wales PW, Kosar C, Carricato M, de Silva N, Lang K, Avitzur Y. Ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients with intestinal failure: preliminary experience. J Pediatr Surg. 2011 May;46(5):951-6. doi: 10.1016/j.jpedsurg.2011.02.036.</citation>
    <PMID>21616259</PMID>
  </reference>
  <reference>
    <citation>Sanders J, Pithie A, Ganly P, Surgenor L, Wilson R, Merriman E, Loudon G, Judkins R, Chambers S. A prospective double-blind randomized trial comparing intraluminal ethanol with heparinized saline for the prevention of catheter-associated bloodstream infection in immunosuppressed haematology patients. J Antimicrob Chemother. 2008 Oct;62(4):809-15. doi: 10.1093/jac/dkn284. Epub 2008 Jul 11.</citation>
    <PMID>18621987</PMID>
  </reference>
  <reference>
    <citation>Chambers ST, Peddie B, Pithie A. Ethanol disinfection of plastic-adherent micro-organisms. J Hosp Infect. 2006 Jun;63(2):193-6. doi: 10.1016/j.jhin.2006.01.009. Epub 2006 Apr 4.</citation>
    <PMID>16600429</PMID>
  </reference>
  <reference>
    <citation>Abu-El-Haija M, Schultz J, Rahhal RM. Effects of 70% ethanol locks on rates of central line infection, thrombosis, breakage, and replacement in pediatric intestinal failure. J Pediatr Gastroenterol Nutr. 2014 Jun;58(6):703-8. doi: 10.1097/MPG.0000000000000354.</citation>
    <PMID>24590214</PMID>
  </reference>
  <reference>
    <citation>Crnich CJ, Halfmann JA, Crone WC, Maki DG. The effects of prolonged ethanol exposure on the mechanical properties of polyurethane and silicone catheters used for intravascular access. Infect Control Hosp Epidemiol. 2005 Aug;26(8):708-14. doi: 10.1086/502607.</citation>
    <PMID>16156328</PMID>
  </reference>
  <reference>
    <citation>Opilla MT, Kirby DF, Edmond MB. Use of ethanol lock therapy to reduce the incidence of catheter-related bloodstream infections in home parenteral nutrition patients. JPEN J Parenter Enteral Nutr. 2007 Jul-Aug;31(4):302-5. doi: 10.1177/0148607107031004302.</citation>
    <PMID>17595439</PMID>
  </reference>
  <reference>
    <citation>Chhim RF, Crill CM, Collier HK, Arnold SR, Pourcyrous M, Meibohm B, Christensen M. Ethanol lock therapy: a pilot infusion study in infants. Ann Pharmacother. 2015 Apr;49(4):431-6. doi: 10.1177/1060028015569881. Epub 2015 Jan 28.</citation>
    <PMID>25632063</PMID>
  </reference>
  <reference>
    <citation>Upadhyayula S, Kambalapalli M, Harrison CJ. Safety of anti-infective agents for skin preparation in premature infants. Arch Dis Child. 2007 Jul;92(7):646-7. doi: 10.1136/adc.2007.117002. No abstract available.</citation>
    <PMID>17588981</PMID>
  </reference>
  <reference>
    <citation>Mermel LA, Alang N. Adverse effects associated with ethanol catheter lock solutions: a systematic review. J Antimicrob Chemother. 2014 Oct;69(10):2611-9. doi: 10.1093/jac/dku182. Epub 2014 Jun 2.</citation>
    <PMID>24891431</PMID>
  </reference>
  <reference>
    <citation>Sharma V, Sharma A, Kumar V, Aggarwal S. Disulfiram-like reaction with ornidazole. J Postgrad Med. 2009 Oct-Dec;55(4):292-3. doi: 10.4103/0022-3859.58940.</citation>
    <PMID>20083883</PMID>
  </reference>
  <reference>
    <citation>Karamanakos PN, Pappas P, Boumba VA, Thomas C, Malamas M, Vougiouklakis T, Marselos M. Pharmaceutical agents known to produce disulfiram-like reaction: effects on hepatic ethanol metabolism and brain monoamines. Int J Toxicol. 2007 Sep-Oct;26(5):423-32. doi: 10.1080/10915810701583010.</citation>
    <PMID>17963129</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>March 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>October 29, 2019</last_update_submitted>
  <last_update_submitted_qc>October 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Materno Infantil Prof. Fernando Figueira</investigator_affiliation>
    <investigator_full_name>Flavia orange</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Central Venous Catheters</keyword>
  <keyword>Child</keyword>
  <keyword>ethanol therapy</keyword>
  <keyword>CLABSI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Catheter-Related Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.cdc.gov/hicpac/bsi/bsi-guidelines-2011.html</doc_url>
      <doc_comment>Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011</doc_comment>
    </study_doc>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.cdc.gov/nhsn/pdfs/pscmanual/4psc_clabscurrent.pdf</doc_url>
      <doc_comment>Bloodstream Infection Event (Central Line-Associated Bloodstream Infection and non-central line-associated Bloodstream Infection)</doc_comment>
    </study_doc>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.cdc.gov/nhsn/pdfs/pscmanual/17pscnosinfdef_current.pdf</doc_url>
      <doc_comment>CDC/NHSN Surveillance Definitions for Specific Types of Infections</doc_comment>
    </study_doc>
  </study_docs>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03253887
org study id: 55008116.8.0000.5201
nct id: NCT03253887
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central venous catheter (CVC) infection is a common complication in pediatric patients,
      resulting in prolonged length of stay in hospital, requiring antibiotics, invasive procedures
      and increase morbidity and mortality. Given the repercussion of this complication, measures
      that minimize its should be stimulated. The purpose of this study is to evaluate the effects
      of intraluminal alcoholization (ethanol lock therapy) on prevention of infection of
      short-term central venous catheters in pediatric patients.
The patients was divided into two groups, where one received alcoholization (ethanol lock
      therapy group) and the other not (control group). The variables evaluated were: CLABSI,
      etiological agents, adverse events and the mechanical effects of ethanol on the catheter
      (breakage and obstruction). To determine the association between the independent variable and
      the dependent variables, the chi-square test of association (Pearson) and Fisher's exact test
      were used. The Risk Ratio (RR) was calculated as a relative risk measure, with its 95%
      confidence interval (95% CI). The significance level of 5% was adopted. The sample size
      calculation was performed in the OpenEpi software version 2.3.1. And a long-term catheter
      clinical trial was used to calculate the sample size, which demonstrated a 9% central venous
      catheter infection frequency in the ethanol group and 37% in the control group, so that the
      sample size was 80 patients (40 in each group), considering a power of 80%, an alpha error of
      5% and 10% of post-randomization losses.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It's a randomized controlled clinical trial.
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Following inclusion, the patients were randomized into two groups, the ethanol-lock group and the control group, using allocation concealment with a list of random numbers generated using the Random Allocation Software
measure: Number of central line associated bloodstream infection (CLABSI) episodes in each group and compare them
time frame: Period from 48 hours after catheter insertion to 24 hours after catheter removal
description: Measure of Central line associated bloodstream infection (CLABSI) rate per 1000 catheter-days compared between the groups, according to CDC's National Healthcare Safety Network (CDC/NHSN) 2015 definitions.
measure: main etiological agents involved in central line associated bloodstream infection (CLABSI) events
time frame: Considering that blood specimens were collected 48 hours after catheter insertion and up to 24 hours after catheter removal, from July 2016 to April 2017.
description: The organisms responsable for each CLABSI event: gram negatives, gram positives or fungus. Identified by one or more blood specimens by a culture or non-culture based microbiologic testing method and the organism(s) identified in blood is not related to an infection at another site
measure: Incidence of Treatment-Emergent Adverse Events
time frame: During the use of ethanol-lock therapy
description: Number of episodes of adverse events (dizziness, headache, dyspnea, chest pain, alcohol taste, facial flushing, nausea, vomiting, pruritus, sneezing, slurred speech, irritability)
measure: Incidence of mechanical effects of ethanol-lock on the catheter (catheter breakage and obstruction)
time frame: During the use of ethanol-lock therapy
description: Evaluate mechanical effects of ethanol-lock on the catheter, by the number of participants with catheter breakage or catheter obstruction in each group
arm group label: Ethanol-lock therapy (ELT) Group
arm group type: Experimental
description: This group received daily alcohol 70% (ethanol-lock) with intraluminal alcoholization of both lumens of the central venous catheters
arm group label: Control Group
arm group type: No Intervention
description: This group did not receive the ethanol-lock, being only followed daily and treated according to the standard protocol in operation at this healthcare unit.
intervention type: Drug
intervention name: Ethanol-lock
description: This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution.
arm group label: Ethanol-lock therapy (ELT) Group
other name: Ethanol 70%
other name: Alcohol 70%
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: No
last name: Bellisa C Lopes, Master
role: Principal Investigator
affiliation: Instituto de Medicina Integral Prof Fernando Figueira
facility: 
country: Brazil
citation: Flynn PM. Diagnosis and management of central venous catheter-related bloodstream infections in pediatric patients. Pediatr Infect Dis J. 2009 Nov;28(11):1016-7. doi: 10.1097/INF.0b013e3181bf7bfc. No abstract available.
PMID: 19859018
citation: Ullman AJ, Cooke ML, Mitchell M, Lin F, New K, Long DA, Mihala G, Rickard CM. Dressings and securement devices for central venous catheters (CVC). Cochrane Database Syst Rev. 2015 Sep 10;2015(9):CD010367. doi: 10.1002/14651858.CD010367.pub2.
PMID: 26358142
citation: Rosado V, Romanelli RM, Camargos PA. Risk factors and preventive measures for catheter-related bloodstream infections. J Pediatr (Rio J). 2011 Nov-Dec;87(6):469-77. doi: 10.2223/JPED.2134.
PMID: 22170387
citation: Subha Rao SD, Joseph MP, Lavi R, Macaden R. Infections related to vascular catheters in a pediatric intensive care unit. Indian Pediatr. 2005 Jul;42(7):667-72.
PMID: 16085967
citation: Cruzeiro PC, Camargos PA, Miranda ME. Central venous catheter placement in children: a prospective study of complications in a Brazilian public hospital. Pediatr Surg Int. 2006 Jun;22(6):536-40. doi: 10.1007/s00383-006-1671-2. Epub 2006 May 5.
PMID: 16736225
citation: Huang EY, Chen C, Abdullah F, Aspelund G, Barnhart DC, Calkins CM, Cowles RA, Downard CD, Goldin AB, Lee SL, St Peter SD, Arca MJ; 2011 American Pediatric Surgical Association Outcomes and Clinical Trials Committee. Strategies for the prevention of central venous catheter infections: an American Pediatric Surgical Association Outcomes and Clinical Trials Committee systematic review. J Pediatr Surg. 2011 Oct;46(10):2000-11. doi: 10.1016/j.jpedsurg.2011.06.017.
PMID: 22008341
citation: Webster J, Gillies D, O'Riordan E, Sherriff KL, Rickard CM. WITHDRAWN: Gauze and tape and transparent polyurethane dressings for central venous catheters. Cochrane Database Syst Rev. 2016 May 4;(5):CD003827. doi: 10.1002/14651858.CD003827.pub3. No abstract available.
PMID: 27144903
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responsible party type: Principal Investigator
investigator affiliation: Instituto Materno Infantil Prof. Fernando Figueira
investigator full name: Flavia orange
investigator title: PhD
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
mesh term: Catheter-Related Infections
mesh term: Ethanol
sharing ipd: No
study doc: 
study doc: 
study doc: 