<?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>IRCT20080825001083N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-05-24</date_registration>
      <primary_sponsor>Rasht University of Medical Sciences</primary_sponsor>
      <public_title>The survey of the effect of cool dialysate on hemodynamic condition and adequacy of dialysis</public_title>
      <acronym></acronym>
      <scientific_title>The survey of the effect of cool dialysate on hemodynamic condition and adequacy of dialysis in hemodialysis patients in Razi hospital, Rasht, Iran, 2019</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>99</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/39635</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Prevention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>CKD.</hc_freetext>
      <i_freetext>Intervention group: This study is done with a sample size of 99 dialysis patients from Razi Hospital who will be selected by simple sampling method. These patients will undergo dialysis with the same dialysis solution for the compounds in them, the same dialysis filters will be dialyzed at each dialysis for each patient and at the same time each time. Initially, each patient undergoes hemodialysis in three consecutive sessions with a dialysis solution of 37 ° C which is the usual temperature for dialysis and is currently used for this hemodialysis temperature at this center. Blood pressure and pulse of the patient Before each dialysis, during (2 hours after the start of dialysis ) and immediately after each dialysis is monitored and recorded. The patient's blood sample is taken to carry out the BUN test before and after the third dialysis so that its results can be used to measure the adequacy of dialysis. In the next three sessions of dialysis, the patient undergoes hemodialysis with a cold dialysis solution at 35.5 ° C, and as before, blood pressure and pulse rates were recorded before, during and after each dialysis, and in the third dialysis, Before and after dialysis, the patient's blood sample is taken for BUN testing. Diastolic and diastolic blood pressure, and the number of pulses recorded at each turn of dialysis, will be used to calculate the mean of these values as well as the difference in mean values at 35.5 ° C and 37 ° C. To monitor patients during dialysis, hemodynamic monitoring and recording, as well as blood sample collection, will be used by one experienced nurse in the dialysis unit as a collaborator. Blood samples taken at two different temperatures are labeled with their number and temperature. After receiving the test responses, the dialysis adequacy ratio (KT / V) for each temperature is calculated and recorded using the formula for the ratio of time clearances to the volume of urea release (KT / V). To calculate KT / V, a computer software that will calculate it based on the Daugirdas II logarithmic formula will be used. To control systolic blood pressure, diastolic blood pressure and pulse rate, the OMRON digital barometer, the Japan-based manufacturing model M3, which is one of the most prominent brands in Iran, will be used..</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:
The final outcome of the study can be shared for all dialysis patients and other people who have a job relationship with these patients. The total potential data can be shared for researchers and students of medical and paramedical groups after unidentifiable individuals.

When:
Start the access period 3 months after printing the results

To whom:
Dialysis patients, Researchers and students of medical and paramedical groups, Academic and Private Institutions

Conditions:
The results of the research do not appear to be applicable to non-medical individuals and private companies. However, if necessary, they can contact the researcher of this research (Dr. Majid Pourshikihian) at 00989113304288 or email : pourshaikhian_m@yahoo.com.

Where to obtain:
Dr.Majid Pourshaikhian - Nursing and Midwifery Faculty of Rasht - 00989113304288 - E-mail : pourshaikhian_m@yahoo.com

How to obtain:
This research is in the form of student dissertation.Therefore,to receive official information and documentation, please contact the Delegation of the Nursing and Midwifery Faculty of Rasht.
To speed up the correspondence process, you can contact the researcher (Dr. Majid Pourshikihan) at (00989113304288) or E-mail : pourshaikhian_m@yahoo.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Majid Pourshaikhian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi eductional &amp; theraputic center, Sardare jangal Ave,</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>41448-95655</zip>
        <telephone>+98 135540415</telephone>
        <email>m_pourshaikhan@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Majid Pourshaikhian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Vice-chancellor for Research, Guilan University of Medical Sciences and Health Services,  Shahid Sia</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4188794755</zip>
        <telephone>+98 13 3360 5768</telephone>
        <email>m_pourshaikhan@gums.ac.ir</email>
        <affiliation>Rasht University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Dialysis patients undergoing hemodialysis three times a week
History of hemodialysis at least three months before the study
The desire to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Cardiovascular Disease
Thyroid Disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I13.11</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hypertensive heart and chronic kidney disease without heart failure, with stage 5 chronic kidney disease, or end stage renal disease</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is done with a sample size of 99 dialysis patients from Razi Hospital who will be selected by simple sampling method. These patients will undergo dialysis with the same dialysis solution for the compounds in them, the same dialysis filters will be dialyzed at each dialysis for each patient and at the same time each time. Initially, each patient undergoes hemodialysis in three consecutive sessions with a dialysis solution of 37 ° C which is the usual temperature for dialysis and is currently used for this hemodialysis temperature at this center. Blood pressure and pulse of the patient Before each dialysis, during (2 hours after the start of dialysis ) and immediately after each dialysis is monitored and recorded. The patient's blood sample is taken to carry out the BUN test before and after the third dialysis so that its results can be used to measure the adequacy of dialysis. In the next three sessions of dialysis, the patient undergoes hemodialysis with a cold dialysis solution at 35.5 ° C, and as before, blood pressure and pulse rates were recorded before, during and after each dialysis, and in the third dialysis, Before and after dialysis, the patient's blood sample is taken for BUN testing. Diastolic and diastolic blood pressure, and the number of pulses recorded at each turn of dialysis, will be used to calculate the mean of these values as well as the difference in mean values at 35.5 ° C and 37 ° C. To monitor patients during dialysis, hemodynamic monitoring and recording, as well as blood sample collection, will be used by one experienced nurse in the dialysis unit as a collaborator. Blood samples taken at two different temperatures are labeled with their number and temperature. After receiving the test responses, the dialysis adequacy ratio (KT / V) for each temperature is calculated and recorded using the formula for the ratio of time clearances to the volume of urea release (KT / V). To calculate KT / V, a computer software that will calculate it based on the Daugirdas II logarithmic formula will be used. To control systolic blood pressure, diastolic blood pressure and pulse rate, the OMRON digital barometer, the Japan-based manufacturing model M3, which is one of the most prominent brands in Iran, will be used.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Systolic blood pressure changes. Timepoint: Initially, during and after dialysis at each stage of hemodialysis. Method of measurement: Digital  manometer.</prim_outcome>
      <prim_outcome>Diastolic blood pressure changes. Timepoint: Initially, during and after dialysis at each stage of hemodialysis. Method of measurement: Digital  manometer.</prim_outcome>
      <prim_outcome>Heart rate changes. Timepoint: Initially, during and after dialysis at each stage of hemodialysis. Method of measurement: Digital  manometer.</prim_outcome>
      <prim_outcome>Adequacy of dialysis. Timepoint: First and the end of third turn of dialysis at two different temperatures. Method of measurement: Measuring blood BUN and calculating based on Daugirdas-II formula.</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>Rasht University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-05-11</approval_date>
        <contact_name>Ethics committee of Guilan university of medical sciences</contact_name>
        <contact_address>Namjo Blv - Shahid Ansari street - Facing the 17 Shahrivar hospital Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
