<?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>IRCT201306268140N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2013-07-14</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of lowering dialysate temperature on the quality of hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Effect of lowering dialysate temperature on the quality of hemodialysis in patients undergoing hemodialysis in 5t Azar hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2013-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8568</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>End stage kidney disease.</hc_freetext>
      <i_freetext>In crossover study, patients are assessed during 24 dialysis sessions; the first group received hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions.&#13;
Each patient gets dialysis once with routine temperature and once with cool dialysate. Patients are assessed during 24 dialysis sessions; the first group receives hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions. During the study, all the dialysis conditions are maintained the same except temperature of dialysate (37°C or 35.5°). All patients are on hemodialysis using GAMRO AK96 hemodialysis machine..</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>Mollaei Einollah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 2 Goran-Sari, Golestan University of Medical Sciences, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1442 6900</telephone>
        <email>Mollaei@goums.ac.ir</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mollaei Einollah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Kilometer 2 Goran-Sari, Golestan University of Medical Sciences, Gorgan</address>
        <city>Gorgan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 17 1442 6900</telephone>
        <email>Mollaei@goums.ac.ir</email>
        <affiliation>Golestan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: the samples are included the patients undergoing hemodialysis at 5th Azar hospital having: hypotension in more than 30 percent of dialysis sessions (more than three sessions), during one month before the study; three times dialysis per week with sodium bicarbonate solution; patients did not receive analgesic, anti- hypertensive and anti-spasm during four hours before of dialysis; no history of chronic infections, heart failure, chronic lung disease, drugs / alcohol abuse or require of  treatment for mental disorders, severe anemia, coronary artery disease; age more than 18 years old and more than three month's dialysis treatment.</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In crossover study, patients are assessed during 24 dialysis sessions; the first group received hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions.&#13;
Each patient gets dialysis once with routine temperature and once with cool dialysate. Patients are assessed during 24 dialysis sessions; the first group receives hemodialysis for 12 sessions using cool dialysate (35.5°C) and the second group is on hemodialysis with standard dialysate temperature (37°C). Then the method of treatment is replaced in two groups for the next 12 sessions. During the study, all the dialysis conditions are maintained the same except temperature of dialysate (37°C or 35.5°). All patients are on hemodialysis using GAMRO AK96 hemodialysis machine.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dialysis adequacy. Timepoint: 5 times. Method of measurement: Laboratory method with URR.</prim_outcome>
      <prim_outcome>Sleep Quality. Timepoint: 3 times. Method of measurement: Petersburg Sleep Quality Index (PSQI) questionnaire.</prim_outcome>
      <prim_outcome>Blood pressure. Timepoint: hourly, before, during and after dialysis. Method of measurement: Blood pressure based on mm Hg, monitoring by Gambro AK96 dialysis machine.</prim_outcome>
      <prim_outcome>Temperature. Timepoint: before and immediately after dialysis. Method of measurement: Thermometer.</prim_outcome>
      <prim_outcome>Muscle cramps. Timepoint: pre, intra &amp; post dialysis. Method of measurement: checklist.</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>Golestan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-03-17</approval_date>
        <contact_name>Golestan University of Medical Sciences</contact_name>
        <contact_address>Kilometer 2 Gorgan sari -Golestan University of Medical Sciences Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
