<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/NCT04479878</url>
  </required_header>
  <id_info>
    <org_study_id>ICM2013/40</org_study_id>
    <nct_id>NCT04479878</nct_id>
  </id_info>
  <brief_title>Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein</brief_title>
  <acronym>ONAC</acronym>
  <official_title>Observational and Monocentric Study of Complications in Adults With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein Initiated in Hospitalization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</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>
      This observational study will evaluate the frequency of complications in adult cancer&#xD;
      patients with central venous parenteral nutrition and the identification of aggravating&#xD;
      factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In oncology, central venous catheters are used for treatments such as chemotherapy,&#xD;
      hydration, antibiotic therapy and parenteral nutrition. However, these catheters are&#xD;
      responsible for serious complications often infectious or vascular. They can lead to&#xD;
      suspension or discontinuation of treatments and can lead to life-threatening outcomes for&#xD;
      patients. The incidence rate and risk factors for central venous catheter-related infections&#xD;
      in oncology remain poorly known. Recently, a prospective study targeted a 5-fold increase in&#xD;
      the risk of catheter infection when parenteral nutrition was associated with chemotherapy.&#xD;
&#xD;
      This is why the indications of parenteral nutrition must be respected and enteral nutrition&#xD;
      promoted where possible.&#xD;
&#xD;
      the investigator conducted a retrospective study in 1998 over 10 years and 6 months,&#xD;
      including all patients who received or received a parenteral nutrition at home, for at least&#xD;
      one month.&#xD;
&#xD;
      Of 153 patients with implantable sites, 181 infectious episodes were recorded in 68 patients&#xD;
      (44.4% of the population) with an estimated median infection rate of 2 infections/patients&#xD;
      (1-12). There was a clear predominance of community-borne skin germs (85% Staphylococcus sp&#xD;
      and 3% multi-resistant bacteria (BMR)).&#xD;
&#xD;
      In order to improve our nursing practices, and reduce complications for patients,the&#xD;
      investigator propose the establishment of an observatory of complications in adults with&#xD;
      cancer benefiting from superior parenteral nutrition on the central venous tract initiated in&#xD;
      hospitalization with a planned return home&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2013</start_date>
  <completion_date type="Actual">May 31, 2015</completion_date>
  <primary_completion_date type="Actual">May 31, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Number and date of infectious complications per patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Number and date of vascular complications per patient</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of care practices</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Assessment of Nurse's Handwashing Every Two Weeks (10-point note)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of care practices</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Evaluation of the consumption of sterile sets (for connections and disconnections on the Central Venous Way) and Huber needles by the provider every two weeks (note on 10 points)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of care practices</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Evaluation of pulsed rinse after nutrition by the nursing office - question asked only once at the end of observation (&quot;never&quot; - &quot;sometimes to often&quot; - &quot;always&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of hospitalizations and central vein ablations</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Collection of the number of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of hospitalizations and central vein ablations</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>Collection of the duration of hospitalizations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of compliance with protocols for the medical care of infectious and vascular complications</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>assessment of adherence to protocols for the management of infectious and vascular complications on a 5-point scale corresponding to the 5 main recommended international steps for infectious complications, and on 1 point (yes/no) according to the parenteral nutrition treaty for vascular complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of serious complications related to the central vein</measure>
    <time_frame>from date of inclusion visit until an average of 1 year</time_frame>
    <description>number of complications related to the central vein per patient</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient With Cancer Receiving an Artificial Parenteral Nutrition in the Central Vein&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Central venous parenteral nutrition initiated in hospitalization with a planned return&#xD;
             home (with parenteral nutrition).&#xD;
&#xD;
          -  Life expectancy &gt; 3 months&#xD;
&#xD;
          -  OMS (World Health Organization) performance status (PS) 0, 1 or 2&#xD;
&#xD;
          -  With initial dietary consultation during hospitalization&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Hospitalized 48 hours or more&#xD;
&#xD;
          -  Patient Information and Signature of Informed Consent&#xD;
&#xD;
          -  patient must be affiliated to a French Social Security System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  OMS&gt; 3 or 4&#xD;
&#xD;
          -  Patient in the process of infection&#xD;
&#xD;
          -  Patient followed up in surgery&#xD;
&#xD;
          -  Patient without central vein&#xD;
&#xD;
          -  Patient with superior cave thrombosis,&#xD;
&#xD;
          -  Inability to undergo medical follow-up of the trial for geographical, social or&#xD;
             psychological reasons,&#xD;
&#xD;
          -  Terminally ill palliative patient, excluding surgery.&#xD;
&#xD;
          -  Patient whose regular follow-up is not possible due to psychological, family, social&#xD;
             or geographical reasons; • Medical or psychological condition which, in the opinion of&#xD;
             the investigator, will not allow the patient to complete the study or sign informed&#xD;
             consent with full knowledge (Article L.1121-6, L.1121-7, L. 1211-8, L. 1211-9);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Lacroix</last_name>
    <role>Study Chair</role>
    <affiliation>ICM Val d'Aurelle</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Icm Val D'Aurelle</name>
      <address>
        <city>Montpellier</city>
        <state>Herault</state>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Toure A, Vanhems P, Lombard-Bohas C, Cassier P, Pere-Verge D, Souquet JC, Ecochard R, Chambrier C. Totally implantable central venous access port infections in patients with digestive cancer: incidence and risk factors. Am J Infect Control. 2012 Dec;40(10):935-9. doi: 10.1016/j.ajic.2012.01.024. Epub 2012 May 26.</citation>
    <PMID>22633131</PMID>
  </results_reference>
  <results_reference>
    <citation>Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.</citation>
    <PMID>19489710</PMID>
  </results_reference>
  <results_reference>
    <citation>O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002 Nov;110(5):e51. doi: 10.1542/peds.110.5.e51.</citation>
    <PMID>12415057</PMID>
  </results_reference>
  <results_reference>
    <citation>Ullmann AJ, Cornely OA, Donnelly JP, Akova M, Arendrup MC, Arikan-Akdagli S, Bassetti M, Bille J, Calandra T, Castagnola E, Garbino J, Groll AH, Herbrecht R, Hope WW, Jensen HE, Kullberg BJ, Lass-Florl C, Lortholary O, Meersseman W, Petrikkos G, Richardson MD, Roilides E, Verweij PE, Viscoli C, Cuenca-Estrella M; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases. Clin Microbiol Infect. 2012 Dec;18 Suppl 7:1-8. doi: 10.1111/1469-0691.12037.</citation>
    <PMID>23137133</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>parenteral nutrition</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04479878
org study id: ICM2013/40
nct id: NCT04479878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This observational study will evaluate the frequency of complications in adult cancer
      patients with central venous parenteral nutrition and the identification of aggravating
      factors.
In oncology, central venous catheters are used for treatments such as chemotherapy,
      hydration, antibiotic therapy and parenteral nutrition. However, these catheters are
      responsible for serious complications often infectious or vascular. They can lead to
      suspension or discontinuation of treatments and can lead to life-threatening outcomes for
      patients. The incidence rate and risk factors for central venous catheter-related infections
      in oncology remain poorly known. Recently, a prospective study targeted a 5-fold increase in
      the risk of catheter infection when parenteral nutrition was associated with chemotherapy.

      This is why the indications of parenteral nutrition must be respected and enteral nutrition
      promoted where possible.

      the investigator conducted a retrospective study in 1998 over 10 years and 6 months,
      including all patients who received or received a parenteral nutrition at home, for at least
      one month.

      Of 153 patients with implantable sites, 181 infectious episodes were recorded in 68 patients
      (44.4% of the population) with an estimated median infection rate of 2 infections/patients
      (1-12). There was a clear predominance of community-borne skin germs (85% Staphylococcus sp
      and 3% multi-resistant bacteria (BMR)).

      In order to improve our nursing practices, and reduce complications for patients,the
      investigator propose the establishment of an observatory of complications in adults with
      cancer benefiting from superior parenteral nutrition on the central venous tract initiated in
      hospitalization with a planned return home
observational model: Other
time perspective: Prospective
measure: Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
time frame: from date of inclusion visit until an average of 1 year
description: Number and date of infectious complications per patient
measure: Prospective assessment of infectious and vascular complications in parenteral nutrition on implanted venous device through systematic registration in relation to care practices
time frame: from date of inclusion visit until an average of 1 year
description: Number and date of vascular complications per patient
measure: Assessment of care practices
time frame: from date of inclusion visit until an average of 1 year
description: Assessment of Nurse's Handwashing Every Two Weeks (10-point note)
measure: Assessment of care practices
time frame: from date of inclusion visit until an average of 1 year
description: Evaluation of the consumption of sterile sets (for connections and disconnections on the Central Venous Way) and Huber needles by the provider every two weeks (note on 10 points)
measure: Assessment of care practices
time frame: from date of inclusion visit until an average of 1 year
description: Evaluation of pulsed rinse after nutrition by the nursing office - question asked only once at the end of observation ("never" - "sometimes to often" - "always")
measure: Evaluation of hospitalizations and central vein ablations
time frame: from date of inclusion visit until an average of 1 year
description: Collection of the number of hospitalizations
measure: Evaluation of hospitalizations and central vein ablations
time frame: from date of inclusion visit until an average of 1 year
description: Collection of the duration of hospitalizations
measure: Evaluation of compliance with protocols for the medical care of infectious and vascular complications
time frame: from date of inclusion visit until an average of 1 year
description: assessment of adherence to protocols for the management of infectious and vascular complications on a 5-point scale corresponding to the 5 main recommended international steps for infectious complications, and on 1 point (yes/no) according to the parenteral nutrition treaty for vascular complications
measure: Evaluation of serious complications related to the central vein
time frame: from date of inclusion visit until an average of 1 year
description: number of complications related to the central vein per patient
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine Lacroix
role: Study Chair
affiliation: ICM Val d'Aurelle
facility: 
country: France
citation: Toure A, Vanhems P, Lombard-Bohas C, Cassier P, Pere-Verge D, Souquet JC, Ecochard R, Chambrier C. Totally implantable central venous access port infections in patients with digestive cancer: incidence and risk factors. Am J Infect Control. 2012 Dec;40(10):935-9. doi: 10.1016/j.ajic.2012.01.024. Epub 2012 May 26.
PMID: 22633131
citation: Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376. Erratum In: Clin Infect Dis. 2010 Apr 1;50(7):1079. Dosage error in article text. Clin Infect Dis. 2010 Feb 1;50(3):457.
PMID: 19489710
citation: O'Grady NP, Alexander M, Dellinger EP, Gerberding JL, Heard SO, Maki DG, Masur H, McCormick RD, Mermel LA, Pearson ML, Raad II, Randolph A, Weinstein RA. Guidelines for the prevention of intravascular catheter-related infections. The Hospital Infection Control Practices Advisory Committee, Center for Disease Control and Prevention, U.S. Pediatrics. 2002 Nov;110(5):e51. doi: 10.1542/peds.110.5.e51.
PMID: 12415057
citation: Ullmann AJ, Cornely OA, Donnelly JP, Akova M, Arendrup MC, Arikan-Akdagli S, Bassetti M, Bille J, Calandra T, Castagnola E, Garbino J, Groll AH, Herbrecht R, Hope WW, Jensen HE, Kullberg BJ, Lass-Florl C, Lortholary O, Meersseman W, Petrikkos G, Richardson MD, Roilides E, Verweij PE, Viscoli C, Cuenca-Estrella M; ESCMID Fungal Infection Study Group. ESCMID* guideline for the diagnosis and management of Candida diseases 2012: developing European guidelines in clinical microbiology and infectious diseases. Clin Microbiol Infect. 2012 Dec;18 Suppl 7:1-8. doi: 10.1111/1469-0691.12037.
PMID: 23137133
responsible party type: Sponsor
sharing ipd: No