<?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>IRCT2016072929116N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-12-07</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparing fluid therapy for kidney transplant surgery guided by PVI (Plethysmography Variability Index) monitoring and conventional fluid therapy in improving transplant kidney function</public_title>
      <acronym></acronym>
      <scientific_title>Comparing fluid therapy guided by PVI (Plethysmography Variability Index) monitoring vs. conventional fluid therapy in improving transplant kidney function and blood lactate levels in kidney transplant patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23485</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Individuals are assigned to control and intervention group randomly via a random numbers table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>End Stage Renal Failure.</hc_freetext>
      <i_freetext>Intervention 1: In the intervention group we use PVI monitoring (plethysmography variablility index) to administer fluids during kidney transplantation surgery.&#13;
We use the Masimo set PVI monitoring. Masimo, Irvine California.&#13;
We use the device to guide the peri-operative fluid therapy during the surgery in the operating room. &#13;
The PVI index is maintained between 10-13 by administering additional crystaloids. as the index rises above 13, 200 mililiters of crystaloids are adminstered and maintenance is given so that the index is always between 10 and 13. If the index is below 10, then all the crystaloids are held except half the maintenance need. Intervention 2: In the control group we administer fluids to the patients by the conventional liberal methods for transplant recipient patients. we give fluids freely to compensate for hemodynamic abnormalities and/or fluid loss and deficits and half the maintenance needs to the patients during surgery.</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>Fardad Iranidoost Haghighi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal-e-ale ahmad St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 21 2235 2772</telephone>
        <email>drfardad@Gmail.comf-iranidoosth@TUMS.ac.ir</email>
        <affiliation>Tehran University Of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Atef Yekta</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shariati Hospital, Jalal-e-ale ahmad St, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>-</zip>
        <telephone>+98 218490000</telephone>
        <email>rezaatefyekta@yahoo.com</email>
        <affiliation>Tehran University Of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Kidney transplant recipients between 18 and 70 years old who are not cases of known cardiomyopathy; AF rhythm; Blood tranfusion during surgery; History of  valve replacement surgery; History of asthma or chronic obstructive pulmonary disease; Morbid obesity; EF&lt;40%, Hb&lt;7; Symptomatic coronary artery diseasse; Prior kidney transplantation history;&#13;
&#13;
Exclusion criteria: peri-operative arrhythmias; peri-operative blood loss more than 1000cc;</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 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 on dialysis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In the intervention group we use PVI monitoring (plethysmography variablility index) to administer fluids during kidney transplantation surgery.&#13;
We use the Masimo set PVI monitoring. Masimo, Irvine California.&#13;
We use the device to guide the peri-operative fluid therapy during the surgery in the operating room. &#13;
The PVI index is maintained between 10-13 by administering additional crystaloids. as the index rises above 13, 200 mililiters of crystaloids are adminstered and maintenance is given so that the index is always between 10 and 13. If the index is below 10, then all the crystaloids are held except half the maintenance need.</i_keyword>
      <i_keyword>In the control group we administer fluids to the patients by the conventional liberal methods for transplant recipient patients. we give fluids freely to compensate for hemodynamic abnormalities and/or fluid loss and deficits and half the maintenance needs to the patients during surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urine Volume. Timepoint: Before and after aortic declamping, 2hours after surgery, The day after surgery, 6 months after surgery. Method of measurement: Reading the Urine bag value.</prim_outcome>
      <prim_outcome>Serum Lactate. Timepoint: Before and after aortic declamping, 2hours after surgery, The day after surgery, 6 months after surgery. Method of measurement: Arterial Blood Gas sample.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Serum creatine. Timepoint: before surgery, The day after surgery. Method of measurement: Biochemistry Lab test.</sec_outcome>
      <sec_outcome>Blood Urea Nitrogen. Timepoint: before surgery, The day after surgery. Method of measurement: Biochemistry Lab test.</sec_outcome>
      <sec_outcome>Arterial Blood Gas (ABG). Timepoint: before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery. Method of measurement: Arterial Blood Gas sampling.</sec_outcome>
      <sec_outcome>Heart Rate per minute. Timepoint: before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery. Method of measurement: Pulse oximetry.</sec_outcome>
      <sec_outcome>Blood Pressure (Mean Arterial Pressure). Timepoint: before surgery, before and after aortic declamp, 2hours after surgery, The day after surgery. Method of measurement: Non Invasive Blood Pressure monitoring.</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>2016-04-04</approval_date>
        <contact_name>Tehran University Of Medical Sciences Medical Ethics Commitee</contact_name>
        <contact_address>Tehran University Of Medical Sciences, Tehran, Iran Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
