<?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>IRCT20180429039463N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-07</date_registration>
      <primary_sponsor>Torbate-Heidaria University of Medical Sciences</primary_sponsor>
      <public_title>Effect of dialysis machine profile on blood pressure</public_title>
      <acronym></acronym>
      <scientific_title>The effect of ascending-descending profile of ultrafiltration along with sodium profile on systolic and diastolic blood pressure during the dialysis process in patients undergoing hemodialysis treatment.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>20</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67695</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Crossover, Purpose: Health service research, Blinding description: In this study, patients will be informed that they will participate in a study, but they will not know that they are in the control group or in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic renal failure.</hc_freetext>
      <i_freetext>Intervention 1: intervention group: In the ascending-descending ultrafiltration profile mode, the duration of dialysis is routinely considered to be 4 hours. Ultrafiltration in this hemodialysis program is divided into three phases (ascending, intermediate and venular). In the ascending phase, 25.5% of the patient's total weight is taken with a low UF rate. In the middle phase, there is an aggressive phase that takes 51.2% of the patient's weight, which is the maximum UF rate in this phase. In the descending phase, 23.6% of the total weight of the patient is taken, and the UF rate of this phase is also low. Intervention 2: Control group: In routine mode without ultrafiltration profile, the patient's weight is divided every hour, weighing is taken to balance. For example, in a patient who has 4 liters of excess weight during 4 hours of hemodialysis, the ultrafiltration rate is 1000 ml per hour.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Information about the main consequence after being unidentified will be shared

When:
Start the access period 6 months after Publish results

To whom:
Everyone

Conditions:
The results obtained in this study can be used without restriction by researchers.

Where to obtain:
Referring to Torbat Heidarieh Nursing and Midwifery Faculty

How to obtain:
After sending the email to the person responsible for the response process begins.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Namazinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95169-33787</zip>
        <telephone>+98 51 5222 6013</telephone>
        <email>mnamazi99@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Namazinia</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Torbat Heydariyeh University of Medical Sciences Building., Razi St., Ferdawsi St</address>
        <city>Torbat Heydariyeh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>95169-33787</zip>
        <telephone>+98 51 5222 6013</telephone>
        <email>mnamazi99@gmail.com</email>
        <affiliation>Torbate-Heidaria University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients aged 18-75
suffering from end-stage renal disease (GFR less than 10% in non-diabetics and non-elderly and GFR less than 15% in diabetics and the elderly)
Being on hemodialysis for more than six months
Dialysis three times a week with sodium bicarbonate buffer solution
Not having specific cardiovascular problems such as heart attack, atrial fibrillation or using a pacemaker
Not having severe anemia</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>75 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Unwillingness to participate in the study
Try to get a vein or needle more than twice in each vascular pathway
Fistula failure</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease (CKD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group: In the ascending-descending ultrafiltration profile mode, the duration of dialysis is routinely considered to be 4 hours. Ultrafiltration in this hemodialysis program is divided into three phases (ascending, intermediate and venular). In the ascending phase, 25.5% of the patient's total weight is taken with a low UF rate. In the middle phase, there is an aggressive phase that takes 51.2% of the patient's weight, which is the maximum UF rate in this phase. In the descending phase, 23.6% of the total weight of the patient is taken, and the UF rate of this phase is also low.</i_keyword>
      <i_keyword>Control group: In routine mode without ultrafiltration profile, the patient's weight is divided every hour, weighing is taken to balance. For example, in a patient who has 4 liters of excess weight during 4 hours of hemodialysis, the ultrafiltration rate is 1000 ml per hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood pressure. Timepoint: In this study, blood pressure is measured before dialysis, the first hour, the second hour, the third hour, the fourth hour, and after each dialysis session. Method of measurement: Each of the samples rested in the supine position after baring the hand with the hand of the sphygmomanometer while the cuff of the device was closed at least 2.5 to 3 cm above the elbow and was measured and recorded.</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>Torbate-Heidaria University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Research Ethics Committee of Torbat Heydariyeh University of Medical Sciences</contact_name>
        <contact_address>Torbat Heydariyeh University of Medical Sciences, Razi St. Torbat Heydariyeh Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
