<?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>IRCT2015031214333N30</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2015-05-07</date_registration>
      <primary_sponsor>Kermanshah University of Medical Sciences</primary_sponsor>
      <public_title>Study of two types of Permanent Hemodialysis Recirculation in Fixed Tip and Split Tip Catheters in chronic renal failure patients</public_title>
      <acronym></acronym>
      <scientific_title>Comparing permanent hemodialysis recirculation with fixed tip and split tip catheters in chronic renal failure patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>164</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic Kidney Disease.</hc_freetext>
      <i_freetext>Intervention 1: In the first group, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. The main needle of fixed tip catheter set will be placed on the needle Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis resumes. Finally, considering the urea level in blood, blood recirculation is measured using three needles method. Intervention 2: In the second groups, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. In the second group the main needle of split tip catheter set will be on the needle. Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis continues. Finally, considering the urea level in blood, blood recirculation is measured using three needles method. .</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname></firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address></address>
        <city></city>
        <country1></country1>
        <zip></zip>
        <telephone></telephone>
        <email></email>
        <affiliation></affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ezatollah Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emamreza hospital, Parastar boulevard</address>
        <city>Kermanshah</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 83 3427 6309</telephone>
        <email>Ezatollahsadeghi@yahoo.com</email>
        <affiliation>Kermanshah University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion: written consent to attend the study by patients; patients with renal failure requiring hemodialysis; age of 16 to 70. Exclusion: patients who experienced central vein catheter.</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, stage 5</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the first group, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. The main needle of fixed tip catheter set will be placed on the needle Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis resumes. Finally, considering the urea level in blood, blood recirculation is measured using three needles method.</i_keyword>
      <i_keyword>In the second groups, after prep and drep the patients and creating proper position in neck extension, internal Jugular vein is found at bifurcation of Sternocleidomastoid muscle in Supraclavicular triangle toward Niple at the same side with needle guide. In the second group the main needle of split tip catheter set will be on the needle. Dialysis will be ceased 30 minutes later at optimal flow 250ml/m. Simultaneously, three blood samples are taken from artery and venous dialysis and also upper extremity vein opposite to catheter embedding. Samples are sent to laboratory to determine their urea levels and dialysis continues. Finally, considering the urea level in blood, blood recirculation is measured using three needles method. .</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Venous blood urea rate. Timepoint: 30 minutes after staring dialysis. Method of measurement: Through laboratory.</prim_outcome>
      <prim_outcome>Arterial blood urea rate. Timepoint: 30 minutes after staring dialysis. Method of measurement: Through laboratory.</prim_outcome>
      <prim_outcome>Peripheral blood urea rate. Timepoint: 30 minutes after staring dialysis. Method of measurement: Through laboratory.</prim_outcome>
      <prim_outcome>Recirculation of blood. Timepoint: Finishing the dialysis. Method of measurement: Based on the formula {(p-a)(p-v)}*100.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Kermanshah University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2014-07-01</approval_date>
        <contact_name>Kermanshah University of Medical Sciences</contact_name>
        <contact_address>Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences Kermanshah  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
