<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20090127001598N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-04-21</date_registration>
      <primary_sponsor>Mahan Med Meymeh Kish</primary_sponsor>
      <public_title>Clinical validation of Smart Flux hemodialysis filter</public_title>
      <acronym></acronym>
      <scientific_title>Clinical validation of Smart Flux hemodialysis filter made by Medica s.p.a company (Italy) with hollow fiber M-PES model, belongs to Mahan Med Meymeh Kish Company, in hemodialysis patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/42002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: For this purpose, we will use the Quadratic Block Randomization method. For this purpose, we use the numbered list of qualified people from the random number table in the computer system. People in Group I mean " Intervention "and C" are Comparison randomized. Eligible patients were randomly assigned to one of two intervention groups, the smart flux filter or routine filter filter control, based on the number I or C. After the random extraction of the numbers of a block, the above procedure is repeated for four patients. The dose will continue to reach the desired sample size.</study_design>
      <phase>3</phase>
      <hc_freetext>Hemodialysis adequacy.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Hemodialysis filter with smart flux brand from Italy Medica s.p.a with halofiber model M-PES-1.5 low and high flux from Mahan Med Meymah Kish will be used for dialysis.Each patient in this group is hemodialysed with this type of filter for two weeks (6 sessions). Intervention 2: Control group: In the comparison or control group, patients are hemodialyzed with approved filters (including meditechsys PS16 and 160 filters based on the type of filters studied using equivalent filters).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is It should be decided in our institutional ethics committee.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Shahram Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Internal Medicine Dept., Al-Zahra Hospital, Soffeh Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3822 0000</telephone>
        <email>sh_taheri@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shahram Taheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Internal Medicine Dept., Al-Zahra Hospital, Soffeh Ave.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174675731</zip>
        <telephone>+98 31 3822 0000</telephone>
        <email>sh_taheri@med.mui.ac.ir</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To be on hemodialysis more than 3 months
Age more than 20 year and less than 75 year.
Have stable clinical and laboratory condition, (Corrected Ca&gt;8mg%, K≤5.5 Hct&gt;20%).
Scheduled regular 3 times weekly hemodialysis program.
Have stable vascular access.
Have stable blood pressure.
Have stable hemodynamic and cardiovascular condition, (for example no heart attack or cerebrovascular events in last three months).
Have no acute infection or malignant tumors
Have no severe anemia ( hematocrit more than 20%)
Patient give informed consent to participate in this clinical trial</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patient has uncontrolled high or low blood pressure (systolic BP less than 90 mmHg or more than 180 mmHg at the start of hemodialysis.
For any reason the patient needs for blood transfusion.
For any reason the patient needs hospitalization.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z49.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for adequacy testing for hemodialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Devices</i_code>
      <i_code>Treatment - Devices</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Hemodialysis filter with smart flux brand from Italy Medica s.p.a with halofiber model M-PES-1.5 low and high flux from Mahan Med Meymah Kish will be used for dialysis.Each patient in this group is hemodialysed with this type of filter for two weeks (6 sessions).</i_keyword>
      <i_keyword>Control group: In the comparison or control group, patients are hemodialyzed with approved filters (including meditechsys PS16 and 160 filters based on the type of filters studied using equivalent filters).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodialysis adequacy. Timepoint: Before starting intervention and at the end of each phase. Method of measurement: laboratory measurement of BUN before and after the dialysis and calculating URR and KT/V.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypotension during and at the end of hemodialysis. Timepoint: At the start of each hemodialysis session and then every hour and at the completion of the hemodialysis session. Method of measurement: Measurement of systolic and diastolic blood pressure by sphygmomanometer.</sec_outcome>
      <sec_outcome>Itching during hemodialysis. Timepoint: During each hemodialysis session. Method of measurement: Observe and record it by the responsible nurse.</sec_outcome>
      <sec_outcome>Clot formation in hemodialysis filter fibers during each hemodialysis session. Timepoint: During each hemodialysis session. Method of measurement: Observe and record it by the responsible nurse.</sec_outcome>
      <sec_outcome>Shortness of breath. Timepoint: ِِDuring each hemodialysis session. Method of measurement: Observed by the nurse in charge and measurement of blood oxygen saturation percentage by pulse oximeter.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Mahan Med Meymeh Kish</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-29</approval_date>
        <contact_name>IR.MUI.RESEARCH</contact_name>
        <contact_address>St. Alzahra Hospital, Soffeh Av. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
