<?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>IRCT2016090329587N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-10-09</date_registration>
      <primary_sponsor>Vice chancellor for research of Tehran University of Medical Sciences.</primary_sponsor>
      <public_title>Effect of lower limb bioimpedance spectroscopy on determining patient 's dry weight and their cardiovascular parameters.</public_title>
      <acronym></acronym>
      <scientific_title>Clinical trial of effect of lower limb bioimpedance spectroscopy on determining patients' dry weight and their cardiovascular parameters in patients with chronic kidney disease under hemodialysis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2016-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>53</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23739</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Diagnostic.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients with chronic kidney disease under hemodialysis...</hc_freetext>
      <i_freetext>Intervention: Determining patient's dry weight with lower limb bioimpedance spectroscopy. Lower limb bioimpedance spectroscopy will be done at supine position in the time of dialysis. Calf resistance will be monitored every 30 minutes in the time of dialysis until extracellular resistance persists despite ultrafiltration continuing. This number represents the estimated dry weight which is determined using bioimpedance spectroscopy. If the patient does not reach the goal dry weight, end dialytic target weight will be reduced 0.2-0.5 Kg in next dialysis sessions. Dry weight will be determined with bioimpedance spectroscopy once at the end of third month after patient reaches the goal dry weight and once at the end of the study (at sixth month). Also, the goal weight will be changed if needed..</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>Dr. Mohamadtaghi Najafi.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam hospital, Keshavarz blvd, Tehran.</address>
        <city>Tehran.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6659 5910</telephone>
        <email>motanjf@gmail.com</email>
        <affiliation>Imam hospital.</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohamadtaghi Najafi.</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam hospital, Keshavarz blvd, Tehran.</address>
        <city>Tehran.</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1419733141</zip>
        <telephone>+98 21 6659 5910</telephone>
        <email>motanjf@gmail.com</email>
        <affiliation>Imam hospital.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Patients older than 18 years old who have the history of dialysis for more than 3 months. Exclusion criteria: Psychiatric diseases; pregnancy; breastfeeding; stage 4 of congestive heart failure; positive history of myocardial infarction or stroke in past 6 months; having cardiac pacemaker or implant; having knee or hip implant; having deep venous thrombosis or lymph edema in lower limb.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</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>Diagnosis</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention: Determining patient's dry weight with lower limb bioimpedance spectroscopy. Lower limb bioimpedance spectroscopy will be done at supine position in the time of dialysis. Calf resistance will be monitored every 30 minutes in the time of dialysis until extracellular resistance persists despite ultrafiltration continuing. This number represents the estimated dry weight which is determined using bioimpedance spectroscopy. If the patient does not reach the goal dry weight, end dialytic target weight will be reduced 0.2-0.5 Kg in next dialysis sessions. Dry weight will be determined with bioimpedance spectroscopy once at the end of third month after patient reaches the goal dry weight and once at the end of the study (at sixth month). Also, the goal weight will be changed if needed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Dry weight. Timepoint: During at frist session of hemodialysis, at third month after patient reaches to her or his gaol dry weight, at sixth month after patient reaches to her or his gaol dry weight. Method of measurement: Lower limb bioimpedance spectroscopy.</prim_outcome>
      <prim_outcome>Pro b-type Natriuretic Peptide. Timepoint: At baesline and at the end of study (when patient entry to our study and six month later when the study end). Method of measurement: blood analysis.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: Before and after dialysis. Method of measurement: Physical examination with sphengomanometer.</sec_outcome>
      <sec_outcome>Sodium. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Potassium. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Adequacy of dialysis. Timepoint: Every month during study. Method of measurement: With measurement of blood urea before and after dialysis and approciate formula for calculation of adequacy of dialysis (Kt/v formula).</sec_outcome>
      <sec_outcome>Albumin. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Blood lipids (triglycerides, cholesterol). Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Complete blood count. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Fasting blood glucose. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Creatinine. Timepoint: Every month during study. Method of measurement: blood analysis.</sec_outcome>
      <sec_outcome>Urea. Timepoint: Every month during study. Method of measurement: blood analysis.</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>Vice chancellor for research of Tehran University of Medical Sciences.</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-11-25</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences.</contact_name>
        <contact_address>Ethics committee of Tehran University of Medical Sciences, Number 23, 4th Floor, 16 Azar street, Keshavarz Blvd,Tehran. Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
