<?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>IRCT201111208140N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2012-03-05</date_registration>
      <primary_sponsor>Golestan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of sodium and ultrafiltration profiles on preventing from the complications made during hemodialysis</public_title>
      <acronym></acronym>
      <scientific_title>Combined effect of sodium and ultrafiltration profiles on some of the common complications during hemodialysis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2012-01-14</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>44</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/8567</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Prevention.</study_design>
      <phase>3</phase>
      <hc_freetext>End stage kidney disease.</hc_freetext>
      <i_freetext>Intervention 1: For each group in this research, four different hemodialysis protocols are implemented. These protocols are as follows: Protocol 1: Linear Sodium Dialysate (150 - 138mEq/L) and constant Ultraﬁltration. Protocol 2: Constant Sodium Dialysate (140 mEq/L) and gradient ultraﬁltration. Protocol 3: Linear Sodium Dialysate (150 - 138 mEq/L) and gradient ultraﬁltration. Protocol 4: (standard hemodialysis) = Constant Sodium Dialysate (140 mEq/L) and constant Ultraﬁltration. Linear Sodium Dialysate: In the first hour of the dialysis the amount of Sodium dialysate is 150mEq/L, then is gradually decreasing by 4mEq/L per hour. In the last hour of the dialysis, it reaches 138mEq/L. Gradient Ultraﬁltration: Two-thirds of the fluid acquired between 2 dialysis sessions is removed during the first two hours of the dialysis and the reset in the last two hours. This protocol can be programmed on Gambro AK96 dialysis machine. Constant Ultraﬁltration: The excessive fluid acquired between hemodialysis is determined. This fluid is taken back in equal volumes in each hour of a four -hour dialysis session. Constant Sodium Dialysate: During a four -hour -dialysis session, sodium dialysate is kept in140 mEq/L. For any patients, six hemodialysis sessions are considered for each of the protocols. For group A, protocols, 1-2-3 and 4 run respectively. Intervention 2: For Group B, protocols, 2-3-4 and 1 run respectively. Intervention 3: For Group C, protocols, 3-4-1 and 2 run respectively. Intervention 4: For Group D, protocols, 4-1-2 and 3 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>Einollah Mollaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences , Kilometer 2 Goran-Sari</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>Einollah Mollaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan University of Medical Sciences, Kilometer 2 Goran-Sari</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: hemodialysis patients in Panje Azar Hospital of Gorgan, who have: 1- hypotension for more than three sessions during last month (20 percent of the sessions). 2- Age of 18-75 years. 3- hemodialysis for more than three months. 4- Dialysis for three times a week with a solution of sodium bicarbonate. 5- End-stage renal diseases. Exclusion criteria: The patients, 1- Before starting dialysis, having systolic blood pressure of below 100 mm Hg. 2- Patients with complications studied in this project (cramps, nausea, vomiting and headache). 3- Administered analgesic, anti-hypertensive and anti-spasmodic, four hours before of dialysis.</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 1: Linear Sodium Dialysate (150 - 138mEq/L) and constant Ultraﬁltration. Protocol 2: Constant Sodium Dialysate (140 mEq/L) and gradient ultraﬁltration. Protocol 3: Linear Sodium Dialysate (150 - 138 mEq/L) and gradient ultraﬁltration. Protocol 4: (standard hemodialysis) = Constant Sodium Dialysate (140 mEq/L) and constant Ultraﬁltration. Linear Sodium Dialysate: In the first hour of the dialysis the amount of Sodium dialysate is 150mEq/L, then is gradually decreasing by 4mEq/L per hour. In the last hour of the dialysis, it reaches 138mEq/L. Gradient Ultraﬁltration: Two-thirds of the fluid acquired between 2 dialysis sessions is removed during the first two hours of the dialysis and the reset in the last two hours. This protocol can be programmed on Gambro AK96 dialysis machine. Constant Ultraﬁltration: The excessive fluid acquired between hemodialysis is determined. This fluid is taken back in equal volumes in each hour of a four -hour dialysis session. Constant Sodium Dialysate: During a four -hour -dialysis session, sodium dialysate is kept in140 mEq/L. For any patients, six hemodialysis sessions are considered for each of the protocols. For group A, protocols, 1-2-3 and 4 run respectively.</i_keyword>
      <i_keyword>For Group B, protocols, 2-3-4 and 1 run respectively.</i_keyword>
      <i_keyword>For Group C, protocols, 3-4-1 and 2 run respectively.</i_keyword>
      <i_keyword>For Group D, protocols, 4-1-2 and 3 run respectively.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: pre, intra &amp; post dialysis. Method of measurement: Blood pressure based on mm Hg, monitoring by Gambro AK96 dialysis machine.</prim_outcome>
      <prim_outcome>Muscle cramps. Timepoint: pre, intra &amp; post dialysis. Method of measurement: checklist.</prim_outcome>
      <prim_outcome>Nausea &amp; vomiting. Timepoint: pre, intra &amp; post dialysis. Method of measurement: with checklist.</prim_outcome>
      <prim_outcome>Headache. Timepoint: pre, intra &amp; post dialysis. Method of measurement: with checklist.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Urea. Timepoint: pre &amp; post dialysis. Method of measurement: Laboratory method.</sec_outcome>
      <sec_outcome>Sodium plasma. Timepoint: pre &amp; post dialysis. Method of measurement: Laboratory method.</sec_outcome>
      <sec_outcome>Plasma osmolality. Timepoint: pre &amp; post dialysis. Method of measurement: Laboratory method.</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>2011-10-30</approval_date>
        <contact_name>Golestan University of Medical Sciences</contact_name>
        <contact_address>Kilometer 2 Gorgan-Sari Gorgan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
