<?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>IRCT2013050613248N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-11-30</date_registration>
      <primary_sponsor>Tehran medical Branch of Islamic azad university</primary_sponsor>
      <public_title>The effect of sodium profile change  and temperature  on preventing from the blood pressure fluctuations  during hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of sodium profile and temperature on blood pressure fluctuations  of patients in hemodialysis section of Imam Hossein hospital in Shahrood ،2013</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-11-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/13166</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>Chronic kidney desease.</hc_freetext>
      <i_freetext>Intervention 1: For each group in this research, four different hemodialysis protocols are implemented. These protocols are as follows: Protocol A:Standard Sodium Dialysate and Standard Temprature. Protocol B: Standard Sodium Dialysate  and low temprature. Protocol C: Linear Sodium Dialysate (150 - 138 mEq/L) andStandard temprature. Protocol D:  Linear Sodium Dialysate (150 mEq/L-138) and low temprature. Linear Sodium Dialysate: In the first hour of the dialysis the amount of Sodium dialysate is 150mEq/L, then is gradually decreasing in per hour. In the last hour of the dialysis, it reaches 138mEq/L.  The low temprature is 35 ° C and  standard temprature is 37° C.For any patients, three hemodialysis sessions are considered for each of the protocols.Standard sodium dialysate: During the 3-hour dialysis session, dialysate sodium of 140 mEq /L is maintained. For group A, protocols, ADBC  run respectively. Intervention 2: For Group B, protocols, BACD run respectively. Intervention 3: For Group C, protocols, CBDA run respectively. Intervention 4: For Group D, protocols, DCAB run respectively.</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>Marzieh hossein Saedee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran medical Branch of Islamic azad university , Khagh ani Ave, shariati st, Tehran</address>
        <city>DAMGHAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671794751</zip>
        <telephone>+98 23 2524 3517</telephone>
        <email>parisan.saeidi@ yahoo.comr</email>
        <affiliation>Tehran medical Branch of Islamic azad university</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Hossein Saedee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tehran medical Branch of Ialamic azad university ،  khagh ani Ave,Shariati St , tehran.</address>
        <city>DAMGHAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3671794751</zip>
        <telephone>+98 23 2524 3517</telephone>
        <email>parisan.saeidi@yahoo.com</email>
        <affiliation>Tehran medical Branch of Islamic Azad universiyu</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria :the patients are between  18t-75  years old؛ they have Chronic Kidney disease ؛  patients must have medical records in hospital and three sessions dialysis weekly؛  Exclusion criteria:  The patients with specific infections disease history؛  Acquired immune deficiency syndrome - coagulopathy- poor nutrition and patients who are using antihypertensive drugs and eating large meals plus patients who have received blood products on hemodialysis sessions؛  The patients with chronic diseases who have hypertension during hemodialysis have also been excluded.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 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>End stage kidney disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>For each group in this research, four different hemodialysis protocols are implemented. These protocols are as follows: Protocol A:Standard Sodium Dialysate and Standard Temprature. Protocol B: Standard Sodium Dialysate  and low temprature. Protocol C: Linear Sodium Dialysate (150 - 138 mEq/L) andStandard temprature. Protocol D:  Linear Sodium Dialysate (150 mEq/L-138) and low temprature. Linear Sodium Dialysate: In the first hour of the dialysis the amount of Sodium dialysate is 150mEq/L, then is gradually decreasing in per hour. In the last hour of the dialysis, it reaches 138mEq/L.  The low temprature is 35 ° C and  standard temprature is 37° C.For any patients, three hemodialysis sessions are considered for each of the protocols.Standard sodium dialysate: During the 3-hour dialysis session, dialysate sodium of 140 mEq /L is maintained. For group A, protocols, ADBC  run respectively</i_keyword>
      <i_keyword>For Group B, protocols, BACD run respectively.</i_keyword>
      <i_keyword>For Group C, protocols, CBDA run respectively</i_keyword>
      <i_keyword>For Group D, protocols, DCAB run respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>BLOOD PRESSURE. Timepoint: Before, during and after the study. Method of measurement: mm/hg.</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>Tehran medical Branch of Islamic azad university</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-05-26</approval_date>
        <contact_name>Shahrood University of Medical Sciences</contact_name>
        <contact_address>university of medical science , Haft-e-tir square , Shahrood shahrood  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
