<?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>IRCT20171009036675N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-03-02</date_registration>
      <primary_sponsor>Zahedan University of Medical Sciences</primary_sponsor>
      <public_title>The effect lowering the dialysate temperature on hemodynamic indicators and dialysis efficiency of  the diabetic patients</public_title>
      <acronym></acronym>
      <scientific_title>The study of effect lowering the dialysate temperature on hemodynamic indicators and dialysis efficiency of  the diabetic patients in aliabn abitalb (AS) hospital of zahedan university of medical sciences in 2018</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/28431</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Chronic kidney disease.</hc_freetext>
      <i_freetext>Intervention group: In this study, 32 hemodialysis patients are selected availably and non-randomly, with inclusion criteria, who are referred to hemodialysis unit of Ali ebn Abitalib hospital in Zahedan. Essential descriptions of how the study is conducted and the purpose of the study is given to patients who are asked to read and sign the written consent form and then with regard to age, gender, occupation, education, and compliance with medical ethics and safety, we complete the demographic information of the patients. Patients undergo hemodialysis in two sessions, once with a cold solution (36 ° C) and the next session with a routine or conventional solution (37 ° C). The hemodialysis variables except for temperature are the same in both cases. The hemoglobin is warmed up to 36.5 to 37.5 ° C (normal range) before the hemodialysis. All patients have one type of dialyser and a dialysis solution (with bicarbonate ) will be used. In the beginning, all machines are verified for the correctness of the function. In order to harmonize the conditions in this study, the rate of fluid harvesting for each patient is determined based on the weight difference before the patient's pure weight loss. The ambient temperature (23 ° C) is controlled throughout the study. The concentration of sodium fluid in dialysis is constant in all sessions. Blindness does not apply to this study.The study is conducted in 2018. All patients who undergo dialysis 3 times a week and 3-4 hours each are included in the study. The hemodialysis fluid flow rate is constant at 500 mm / min with a Fresenius 4008-B apparatus and the same ultrafiltration with the same filtration rate, which is constant for all patients during the study. The fluid withdrawal rate for each patient was calculated before the dialysis weight was calculated with the patient's dry weight and the machine's total weight The accuracy and accuracy of the device, blood pressure, and blood pressure of 8 patients are measured 5 times in a 5-minute sitting period. The systolic and diastolic blood pressure of the patients is measured by a digital doped barometric In the early stages of dialysis, during the first, second and third days of dialysis, and immediately after the end of dialysis, the patient's heart rate is measured at the same time as the blood pressure and the same device. Before and after After each dialysis session, the temperature of the mufflers is measured and recorded. In addition, if the patient complains at least one of the symptoms of hypotension, such as muscle cramps, nausea, vomiting, fatigue and dizziness, his blood pressure will be measured at the same time. The number of times the pressure drop and the changes in pressure and number of actions are necessary. In order to heal, the difference in blood pressure is the difference between the systolic and diastolic blood pressure during dialysis, as well as systolic and diastolic blood pressure, and the onset of dialysis. The mean arterial pressure (MAP) is calculated from the sum of systolic and dihidrostheol divided by 3 times. The patient's time is hypotension, with systolic blood pressure lower than 90 mm Hg. In patients whose baseline blood pressure is 100-90 mm Hg , A 25% drop or a decrease of 20 mm in excess of systolic pressure as hypotension. Dialysis adequacy means that dialysis takes up 70% or more of blood urea over a 4-hour dialysis period, and subsequent administration of dialysis should be based on a higher or at least 70% withdrawal rate. The procedure is that in the final dialysis session before dialysis immediately after insertion of the catheter into the patient's artery Also, at the end of the same dialysis session, the blood flow rate was reduced to 100 ms / min for 10 seconds, and blood samples were taken before and after dialysis for measurement of urea, creatinine, sodium and potassium, and sent to the laboratory. The above tests are routine The monthly is done in the dialysis department Rabbo importance of maintaining the level of serum sodium, potassium, dialysis patients these tests along with urea and creatinine is measured.   100 * urea pre-dialysis / urea dialysis lateral dialysis = URR To calculate the adequacy of dialysis, we use the second generation of Dagridas formula, which is an acceptable formula of the world. In this formula, the natural logarithm, the duration of each hemodialysis session per hour, the proportion of urea after dialysis to pre-dialysis, the weight of the dialysis and the volume of the ultrasound Filtration is on.  KT / V = ​​1.2 100. Urea pre-dialysis / urea dialysis after previous dialysis = URR KT / V = ​​-Ln (R-0/008 × T) + (4--3 / 5T) × 0 / 55UF / V KT / V = ​​Ln (1-URR) It should be noted that according to the division of tasks, data recording, group assignment and their matching are done by the student. Performing dialysis, blood pressure measurements and sampling by nurse, researcher and researcher. Advice and guidance will be provided at all stages by advisor professors..</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:
Only the original outcome data will be available

When:
After publishing the article in 2018

To whom:
all people

Conditions:
Improve treatment conditions

Where to obtain:
Zahedan University of Medical Sciences

How to obtain:
Applying from the university research vice president

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>faculty of nursing and midwifery, Mashahir sq.</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3344 2481</telephone>
        <email>f.kiani@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>fatemeh kiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>faculty of nursing and midwifery - Mashahir sq.</address>
        <city>zahedan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9816743463</zip>
        <telephone>+98 54 3344 2481</telephone>
        <email>f.kiani@zaums.ac.ir</email>
        <affiliation>Zahedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients should have a history of hemodialysis at least three months before the study
Non-use of blood pressure reducing drugs is one of the inclusion criterias
Patients should have less than 2 kg of weight gain during dialysis
Patients who have experienced  less than 90 mm Hg systolic pressure in previous sessions of dialysis and experienced related symptoms are included in the study.
Patients should not have severe anemia (8Hb &lt;)
Patients should not have simultaneous malignancies
Not having thyroid disorders is also one of the the inclusion criterias.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>patient's death
Incompatible dialysis with cold solution (in case of very severe chills).
Consumption of food and fluids is higher than the amount prescribed during dialysis
Unwillingness to continue participating in the study</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In this study, 32 hemodialysis patients are selected availably and non-randomly, with inclusion criteria, who are referred to hemodialysis unit of Ali ebn Abitalib hospital in Zahedan. Essential descriptions of how the study is conducted and the purpose of the study is given to patients who are asked to read and sign the written consent form and then with regard to age, gender, occupation, education, and compliance with medical ethics and safety, we complete the demographic information of the patients. Patients undergo hemodialysis in two sessions, once with a cold solution (36 ° C) and the next session with a routine or conventional solution (37 ° C). The hemodialysis variables except for temperature are the same in both cases. The hemoglobin is warmed up to 36.5 to 37.5 ° C (normal range) before the hemodialysis. All patients have one type of dialyser and a dialysis solution (with bicarbonate ) will be used. In the beginning, all machines are verified for the correctness of the function. In order to harmonize the conditions in this study, the rate of fluid harvesting for each patient is determined based on the weight difference before the patient's pure weight loss. The ambient temperature (23 ° C) is controlled throughout the study. The concentration of sodium fluid in dialysis is constant in all sessions. Blindness does not apply to this study.The study is conducted in 2018. All patients who undergo dialysis 3 times a week and 3-4 hours each are included in the study. The hemodialysis fluid flow rate is constant at 500 mm / min with a Fresenius 4008-B apparatus and the same ultrafiltration with the same filtration rate, which is constant for all patients during the study. The fluid withdrawal rate for each patient was calculated before the dialysis weight was calculated with the patient's dry weight and the machine's total weight The accuracy and accuracy of the device, blood pressure, and blood pressure of 8 patients are measured 5 times in a 5-minute sitting period. The systolic and diastolic blood pressure of the patients is measured by a digital doped barometric In the early stages of dialysis, during the first, second and third days of dialysis, and immediately after the end of dialysis, the patient's heart rate is measured at the same time as the blood pressure and the same device. Before and after After each dialysis session, the temperature of the mufflers is measured and recorded. In addition, if the patient complains at least one of the symptoms of hypotension, such as muscle cramps, nausea, vomiting, fatigue and dizziness, his blood pressure will be measured at the same time. The number of times the pressure drop and the changes in pressure and number of actions are necessary. In order to heal, the difference in blood pressure is the difference between the systolic and diastolic blood pressure during dialysis, as well as systolic and diastolic blood pressure, and the onset of dialysis. The mean arterial pressure (MAP) is calculated from the sum of systolic and dihidrostheol divided by 3 times. The patient's time is hypotension, with systolic blood pressure lower than 90 mm Hg. In patients whose baseline blood pressure is 100-90 mm Hg , A 25% drop or a decrease of 20 mm in excess of systolic pressure as hypotension. Dialysis adequacy means that dialysis takes up 70% or more of blood urea over a 4-hour dialysis period, and subsequent administration of dialysis should be based on a higher or at least 70% withdrawal rate. The procedure is that in the final dialysis session before dialysis immediately after insertion of the catheter into the patient's artery Also, at the end of the same dialysis session, the blood flow rate was reduced to 100 ms / min for 10 seconds, and blood samples were taken before and after dialysis for measurement of urea, creatinine, sodium and potassium, and sent to the laboratory. The above tests are routine The monthly is done in the dialysis department Rabbo importance of maintaining the level of serum sodium, potassium, dialysis patients these tests along with urea and creatinine is measured.   100 * urea pre-dialysis / urea dialysis lateral dialysis = URR To calculate the adequacy of dialysis, we use the second generation of Dagridas formula, which is an acceptable formula of the world. In this formula, the natural logarithm, the duration of each hemodialysis session per hour, the proportion of urea after dialysis to pre-dialysis, the weight of the dialysis and the volume of the ultrasound Filtration is on.  KT / V = ​​1.2 100. Urea pre-dialysis / urea dialysis after previous dialysis = URR KT / V = ​​-Ln (R-0/008 × T) + (4--3 / 5T) × 0 / 55UF / V KT / V = ​​Ln (1-URR) It should be noted that according to the division of tasks, data recording, group assignment and their matching are done by the student. Performing dialysis, blood pressure measurements and sampling by nurse, researcher and researcher. Advice and guidance will be provided at all stages by advisor professors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hemodynamic indicators. Timepoint: Before and after the intervention. Method of measurement: By thermometer and manometer.</prim_outcome>
      <prim_outcome>Dialysis Efficiency. Timepoint: Before and after the intervention. Method of measurement: Based on the KT/V dialysis quality determination formula, more than 1.2 or less than 1.2.</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>Zahedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-12-24</approval_date>
        <contact_name>Ethics Committee of Zahedan University of Medical Sciences</contact_name>
        <contact_address>Zahedan University of Medical Sciences, Dr Hesabi Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
