<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/NCT03299868</url>
  </required_header>
  <id_info>
    <org_study_id>SEPTIC II</org_study_id>
    <nct_id>NCT03299868</nct_id>
  </id_info>
  <brief_title>Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients</brief_title>
  <official_title>Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan Hospital</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>
      To establish the IV access strategy for terminally ill cancer patients, using comparisons of&#xD;
      the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC&#xD;
      insertion group (routine PICC group) and general IV access group (optional PICC group).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reliable intravenous (IV) access is an important issue in terminally ill cancer patients,&#xD;
      however, they have limited or no peripheral venous access due to edema or long period of IV&#xD;
      therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).&#xD;
&#xD;
      There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC),&#xD;
      chemo-port (CP), and the peripherally inserted central catheter (PICC).&#xD;
&#xD;
      When considering the characteristics of terminally ill cancer patients, such as poor general&#xD;
      condition and a limited period of survival, PICC could be a safe and effective method for&#xD;
      intravenous access.&#xD;
&#xD;
      There are two previous studies concerned about PICC study in terminally ill cancer patients.&#xD;
      They showed that PICC might be overall safe and efficient in terminally ill cancer patients.&#xD;
      However, these studies did not evaluate superiority of PICC insertion compared to no&#xD;
      insertion and the appropriate time for PICC insertion due to limitation of their design, such&#xD;
      as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV&#xD;
      access in terminally ill cancer patients have not been determined until now.&#xD;
&#xD;
      Considering the favorable results of PICC insertion in previous studies and limited survival&#xD;
      time of terminally ill cancer patients, the investigator postulated that routine PICC&#xD;
      insertion at the time of admission for terminal care would be effective for IV access.&#xD;
&#xD;
      Thus, the investigator assumed that initially routine PICC insertion would be non-inferior in&#xD;
      maintenance success rate / and complication rate compared to general IV access. In addition,&#xD;
      it would be superior in patient-perceived satisfaction. The inveistigator will undertake a&#xD;
      randomized phase II study to confirm the hypothesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 2</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>Prospective, Single institution, Open-label, Randomized, Phase 2</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IV access maintenance success rate</measure>
    <time_frame>From date of enrollment until death or discharge/transfer, assess up to 2 years</time_frame>
    <description>rate of successful PICC maintenance until death or discharge/transfer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PICC related complication rate</measure>
    <time_frame>From date of enrollment until death or discharge/transfer, assess up to 2 years</time_frame>
    <description>rate of any complication which is related with PICC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PICC premature removal rate</measure>
    <time_frame>From date of enrollment until date of PICC removal, assess up to 2 years</time_frame>
    <description>rate of premature removal such as self-removal or CRBSI before death or discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PICC life span</measure>
    <time_frame>From date of enrollment until death or discharge/transfer, assess up to 2 years</time_frame>
    <description>median survival of PICC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient perceived procedure-related distress</measure>
    <time_frame>5th day after procedure</time_frame>
    <description>procedure-related distress during insertion of PICC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient perceived comfort and convenience assessed by a newly developed question in this study</measure>
    <time_frame>3th to 7th day after enrollment</time_frame>
    <description>patient perceived comfort and convenience (&quot;How do participants feel comfort and convenience about the IV access?&quot; at 3th - 7th days after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>colonization of microbiology in PICC</measure>
    <time_frame>at the time of PICC removal, assess up to 2 years</time_frame>
    <description>Investigator evaluate the colonization of PICC using tip culture at the time of removal</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Peripherally Inserted Central Catheter</condition>
  <condition>Intravenous Access</condition>
  <arm_group>
    <arm_group_label>Routine PICC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PICC is initially routine insertion at the time of admission of hospice-palliative care unit</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General IV group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>peripherally inserted central catheter (PICC)</intervention_name>
    <description>comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)</description>
    <arm_group_label>General IV group</arm_group_label>
    <arm_group_label>Routine PICC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cancer patients with histologically or cytologically confirmed malignancy and&#xD;
             fulfilled all of the following conditions&#xD;
&#xD;
          2. Patients with expected survival time of 3 months or less due to a progressive disease&#xD;
             without additional anticancer treatment. (However, palliative radiation treatment for&#xD;
             symptom control is allowed.)&#xD;
&#xD;
          3. Patients who need the IV access route continuously for hydration or medication.&#xD;
&#xD;
          4. Age18 or older&#xD;
&#xD;
          5. Signed and dated informed consent of document indicating that the patient (or legally&#xD;
             acceptable representative) has been informed about all pertinent aspects of the trial&#xD;
             prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who showed severe coagulopathy such as thrombocytopenia (Platelet count ≤&#xD;
             20,000/mm2) or international normalized ratio (INR) prolongation (≥2.0 ) in spite of&#xD;
             treatment&#xD;
&#xD;
          2. Patients who have an evidence of current sepsis (bacteremia or fungemia)&#xD;
&#xD;
               1. 'current' means bacteremia/fungemia without eradication on follow-up peripheral&#xD;
                  blood culture&#xD;
&#xD;
               2. patients with persistent fever (bacteremia or fungemia cannot be ruled out)&#xD;
&#xD;
          3. Patients who is impracticable to PICC insertion due to uncontrolled behavioral&#xD;
             disorders&#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>Kwonoh Park, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Yangsan</city>
        <state>Gyeongsangnam-do</state>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.</citation>
    <PMID>11034629</PMID>
  </results_reference>
  <results_reference>
    <citation>Bruera E, Sala R, Rico MA, Moyano J, Centeno C, Willey J, Palmer JL. Effects of parenteral hydration in terminally ill cancer patients: a preliminary study. J Clin Oncol. 2005 Apr 1;23(10):2366-71. doi: 10.1200/JCO.2005.04.069.</citation>
    <PMID>15800328</PMID>
  </results_reference>
  <results_reference>
    <citation>Mercadante S, Ferrera P, Girelli D, Casuccio A. Patients' and relatives' perceptions about intravenous and subcutaneous hydration. J Pain Symptom Manage. 2005 Oct;30(4):354-8. doi: 10.1016/j.jpainsymman.2005.04.004.</citation>
    <PMID>16256899</PMID>
  </results_reference>
  <results_reference>
    <citation>Lam S, Scannell R, Roessler D, Smith MA. Peripherally inserted central catheters in an acute-care hospital. Arch Intern Med. 1994 Aug 22;154(16):1833-7.</citation>
    <PMID>8053751</PMID>
  </results_reference>
  <results_reference>
    <citation>Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. doi: 10.4065/72.3.225.</citation>
    <PMID>9070197</PMID>
  </results_reference>
  <results_reference>
    <citation>Raad I, Davis S, Becker M, Hohn D, Houston D, Umphrey J, Bodey GP. Low infection rate and long durability of nontunneled silastic catheters. A safe and cost-effective alternative for long-term venous access. Arch Intern Med. 1993 Aug 9;153(15):1791-6.</citation>
    <PMID>8392831</PMID>
  </results_reference>
  <results_reference>
    <citation>Smith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg. 1998 Aug;176(2):208-11. doi: 10.1016/s0002-9610(98)00121-4.</citation>
    <PMID>9737634</PMID>
  </results_reference>
  <results_reference>
    <citation>Park K, Jun HJ, Oh SY. Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study. Support Care Cancer. 2016 Dec;24(12):4987-4992. doi: 10.1007/s00520-016-3360-6. Epub 2016 Jul 26.</citation>
    <PMID>27460015</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 22, 2020</last_update_submitted>
  <last_update_submitted_qc>August 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Kwonoh Park, MD phD</investigator_full_name>
    <investigator_title>Professor, clinical research</investigator_title>
  </responsible_party>
  <keyword>Peripherally inserted central catheter</keyword>
  <keyword>Terminally ill cancer patients</keyword>
  <keyword>Palliative care</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/NCT03299868
org study id: SEPTIC II
nct id: NCT03299868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To establish the IV access strategy for terminally ill cancer patients, using comparisons of
      the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC
      insertion group (routine PICC group) and general IV access group (optional PICC group).
Reliable intravenous (IV) access is an important issue in terminally ill cancer patients,
      however, they have limited or no peripheral venous access due to edema or long period of IV
      therapy. Thus, intravenous access has been provided by Central venous catheter (CVC).

      There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC),
      chemo-port (CP), and the peripherally inserted central catheter (PICC).

      When considering the characteristics of terminally ill cancer patients, such as poor general
      condition and a limited period of survival, PICC could be a safe and effective method for
      intravenous access.

      There are two previous studies concerned about PICC study in terminally ill cancer patients.
      They showed that PICC might be overall safe and efficient in terminally ill cancer patients.
      However, these studies did not evaluate superiority of PICC insertion compared to no
      insertion and the appropriate time for PICC insertion due to limitation of their design, such
      as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV
      access in terminally ill cancer patients have not been determined until now.

      Considering the favorable results of PICC insertion in previous studies and limited survival
      time of terminally ill cancer patients, the investigator postulated that routine PICC
      insertion at the time of admission for terminal care would be effective for IV access.

      Thus, the investigator assumed that initially routine PICC insertion would be non-inferior in
      maintenance success rate / and complication rate compared to general IV access. In addition,
      it would be superior in patient-perceived satisfaction. The inveistigator will undertake a
      randomized phase II study to confirm the hypothesis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, Single institution, Open-label, Randomized, Phase 2
primary purpose: Treatment
masking: None (Open Label)
measure: IV access maintenance success rate
time frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
description: rate of successful PICC maintenance until death or discharge/transfer
measure: PICC related complication rate
time frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
description: rate of any complication which is related with PICC
measure: PICC premature removal rate
time frame: From date of enrollment until date of PICC removal, assess up to 2 years
description: rate of premature removal such as self-removal or CRBSI before death or discharge
measure: PICC life span
time frame: From date of enrollment until death or discharge/transfer, assess up to 2 years
description: median survival of PICC
measure: patient perceived procedure-related distress
time frame: 5th day after procedure
description: procedure-related distress during insertion of PICC
measure: patient perceived comfort and convenience assessed by a newly developed question in this study
time frame: 3th to 7th day after enrollment
description: patient perceived comfort and convenience ("How do participants feel comfort and convenience about the IV access?" at 3th - 7th days after enrollment
measure: colonization of microbiology in PICC
time frame: at the time of PICC removal, assess up to 2 years
description: Investigator evaluate the colonization of PICC using tip culture at the time of removal
arm group label: Routine PICC group
arm group type: Experimental
description: PICC is initially routine insertion at the time of admission of hospice-palliative care unit
arm group label: General IV group
arm group type: Active Comparator
description: PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access
intervention type: Device
intervention name: peripherally inserted central catheter (PICC)
description: comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)
arm group label: General IV group
arm group label: Routine PICC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kwonoh Park, MD, PhD
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital
facility: 
country: Korea, Republic of
citation: Cleeland CS. Cancer-related symptoms. Semin Radiat Oncol. 2000 Jul;10(3):175-90. doi: 10.1053/srao.2000.6590.
PMID: 11034629
citation: Bruera E, Sala R, Rico MA, Moyano J, Centeno C, Willey J, Palmer JL. Effects of parenteral hydration in terminally ill cancer patients: a preliminary study. J Clin Oncol. 2005 Apr 1;23(10):2366-71. doi: 10.1200/JCO.2005.04.069.
PMID: 15800328
citation: Mercadante S, Ferrera P, Girelli D, Casuccio A. Patients' and relatives' perceptions about intravenous and subcutaneous hydration. J Pain Symptom Manage. 2005 Oct;30(4):354-8. doi: 10.1016/j.jpainsymman.2005.04.004.
PMID: 16256899
citation: Lam S, Scannell R, Roessler D, Smith MA. Peripherally inserted central catheters in an acute-care hospital. Arch Intern Med. 1994 Aug 22;154(16):1833-7.
PMID: 8053751
citation: Ng PK, Ault MJ, Ellrodt AG, Maldonado L. Peripherally inserted central catheters in general medicine. Mayo Clin Proc. 1997 Mar;72(3):225-33. doi: 10.4065/72.3.225.
PMID: 9070197
citation: Raad I, Davis S, Becker M, Hohn D, Houston D, Umphrey J, Bodey GP. Low infection rate and long durability of nontunneled silastic catheters. A safe and cost-effective alternative for long-term venous access. Arch Intern Med. 1993 Aug 9;153(15):1791-6.
PMID: 8392831
citation: Smith JR, Friedell ML, Cheatham ML, Martin SP, Cohen MJ, Horowitz JD. Peripherally inserted central catheters revisited. Am J Surg. 1998 Aug;176(2):208-11. doi: 10.1016/s0002-9610(98)00121-4.
PMID: 9737634
citation: Park K, Jun HJ, Oh SY. Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study. Support Care Cancer. 2016 Dec;24(12):4987-4992. doi: 10.1007/s00520-016-3360-6. Epub 2016 Jul 26.
PMID: 27460015
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Kwonoh Park, MD phD
investigator title: Professor, clinical research
sharing ipd: No