<?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>IRCT2017040833295N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-07-27</date_registration>
      <primary_sponsor>Shahrood University of Medical Sciences</primary_sponsor>
      <public_title>The effect of the gradual change in liquid sodium dialysis hypotension and cramps and blood sodium dialysis patients</public_title>
      <acronym>interventional</acronym>
      <scientific_title>The effect of the gradual reduction of liquid sodium dialysis hypotension, muscle cramps and plasma sodium levels in hemodialysis patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>106</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25722</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: Patients in the control group treated with routine method (sodium dialysis solution 138 meq per liter in total duration of dialysis) for three sessions of dialysis and then both intervention and control groups for a week routine dialysis were (Wash Out) using cross over of patients in the two groups will change and both groups for one week (three days) dialysis will be in both patients twice a week dialysis during the three sessions of dialysis evaluated fall. Intervention 2: Intervention group patients on hemodialysis with the gradual reduction of sodium dialysis solution (starting with 150 meq per liter and cut it every 15 minutes, and then maintain this concentration) for one week (three days) will be dialysis. Both intervention and control groups for a week routine dialysis were (Wash Out) then using a cross over of patients in both groups will change and both groups for one week (three days) Dialysis and will both groups of patients who are on dialysis twice a week during the three sessions of dialysis evaluated.</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>Uosra Majidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kosar hospital</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 31420</telephone>
        <email>uosra1365.majidi@gmail.com</email>
        <affiliation>Shahrood University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Ali Abbasi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hafte-Tir Square</address>
        <city>Shahrood</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 23 3239 5054</telephone>
        <email>abbasi_msn@yahoo.com</email>
        <affiliation>Shahrood University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria include patients with end-stage renal failure (ESRD); patients aged between 75 and 18, who have been undergoing hemodialysis 2-3 times a week for at least two months; and patients who are willing to participate in the plan. Exclusion criteria include patients who use anti-cramp medication; patients who are not under the control of their physician's blood pressure department; use of medications to lower blood pressure in the morning before dialysis; heart disease, such as heart attack, over a period of six months Recent; patients with discharge fraction of less than 30%; the presence of pacemakers in patients.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N19</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unspecified kidney failure</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Patients in the control group treated with routine method (sodium dialysis solution 138 meq per liter in total duration of dialysis) for three sessions of dialysis and then both intervention and control groups for a week routine dialysis were (Wash Out) using cross over of patients in the two groups will change and both groups for one week (three days) dialysis will be in both patients twice a week dialysis during the three sessions of dialysis evaluated fall.</i_keyword>
      <i_keyword>Intervention group patients on hemodialysis with the gradual reduction of sodium dialysis solution (starting with 150 meq per liter and cut it every 15 minutes, and then maintain this concentration) for one week (three days) will be dialysis. Both intervention and control groups for a week routine dialysis were (Wash Out) then using a cross over of patients in both groups will change and both groups for one week (three days) Dialysis and will both groups of patients who are on dialysis twice a week during the three sessions of dialysis evaluated.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: Before dialysis, first, second and third and fourth hours of dialysis, the dialysis. Method of measurement: -Br millimeters of mercury using mercury manometer.</prim_outcome>
      <prim_outcome>Muscle cramps. Timepoint: Before dialysis, during dialysis, the dialysis. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Plasma sodium. Timepoint: Before dialysis, the dialysis. Method of measurement: In terms of mEq per liter by laboratories.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hypotension during dialysis. Timepoint: Before dialysis, during dialysis, the dialysis. Method of measurement: -Br millimeters of mercury using mercury manometer.</sec_outcome>
      <sec_outcome>Magnesium is the blood. Timepoint: Pre-dialysis and dialysis later. Method of measurement: Mg / dl.</sec_outcome>
      <sec_outcome>Calcium of the blood. Timepoint: Pre-dialysis and dialysis later. Method of measurement: Mg / dl.</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>Shahrood University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-05-24</approval_date>
        <contact_name>Shahroud University of Medical Sciences</contact_name>
        <contact_address>7th Tir Square, Shahroud University of Medical Sciences Shahroud  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
