<?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>IRCT20180407039222N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-07-08</date_registration>
      <primary_sponsor>Shahid Rajaee Cardiovascular Center Tehran</primary_sponsor>
      <public_title>Comparison of Ringer and Ringer Lactate Solution on Acidose and Lactate Status in Pediatric Heart Surgery</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of effect of ringer's solution and lactated ringer as prime solution on acidosis and lactate level in noncyanotic pediatric cardiac surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/30995</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization, lottery through sealed envelopes, Blinding description: Participating patients,Responsible perfusionist and Responsible for data collection were kept blind.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Metabolic Acidosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first group, a lactate ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l  of prime solution and  Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of lactated ringer solution will be about 350-400 cc and once at the start of the bypass.The Ringer Lactate solution is the product of Shahid Ghazi Tabriz factory and made in Iran. Intervention 2: Control group:  In the second group, a ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l  of prime solution and  Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of Ringer's solution will be about 350-400 cc and once at the start of the bypass.Ringer's solution is the product of Iranian Pharmaceutical &amp; Parenteral Products factory and made in Iran.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Patient privacy</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Davood Samiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19956114331</zip>
        <telephone>+98 21 2392 2454</telephone>
        <email>samdvd1979@yahoo.com</email>
        <affiliation>Shahid Rajaee Cardiovascular Center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Davood Samiei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>19956114331</zip>
        <telephone>+98 21 2392 2454</telephone>
        <email>samdvd1979@yahoo.com</email>
        <affiliation>Shahid Rajai Cardiovascular Center</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Children with non-cyanotropic heart disease
Having consent from the parents of the patient
Non-emergency surgery
Absence of coagulation disorders
Absence of anemia (hemoglobin less than 10 g / dl)
Absence of hepatic impairment
Absence of kidney failure
Absence of lung failure
Absence of diabetes
Absence of acid disorder and severe preoperative hypertension
Lactate levels greater than 2 mM per liter before surgery
Not having a  history of heart surgery (redo)
Age 12 to 48 months</inclusion_criteria>
      <agemin>12 months</agemin>
      <agemax>48 months</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Periods of arterial blood pressure reduction before surgery
Ultrafiltration during bypass</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E87.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acidosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first group, a lactate ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l  of prime solution and  Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of lactated ringer solution will be about 350-400 cc and once at the start of the bypass.The Ringer Lactate solution is the product of Shahid Ghazi Tabriz factory and made in Iran.</i_keyword>
      <i_keyword>Control group:  In the second group, a ringer solution will be used to prepare the cardiopulmonary bypass system.Also, the venofundin 6% etherified starch solution at 15 cc / kg body weight, heparin 3 units per ml of prime solution, sodium bicarbonate at 24 mEq / l  of prime solution and  Mannitol 0.5 grams per kilogram of body weight will be added.In the case of low hematocrit, packed cell will also be used.The amount of Ringer's solution will be about 350-400 cc and once at the start of the bypass.Ringer's solution is the product of Iranian Pharmaceutical &amp; Parenteral Products factory and made in Iran.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>PH level. Timepoint: Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass. Method of measurement: Arterial blood sample and arterial gas analyzer.</prim_outcome>
      <prim_outcome>Blood lactate level. Timepoint: Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass. Method of measurement: Arterial blood samples and Care diagnostica machine.</prim_outcome>
      <prim_outcome>Arterial blood bicarbonate level. Timepoint: Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass. Method of measurement: Arterial blood sample and arterial gas analyzer.</prim_outcome>
      <prim_outcome>Arterial base excess level. Timepoint: Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass. Method of measurement: Arterial blood sample and arterial gas analyzer.</prim_outcome>
      <prim_outcome>Arterial blood chloride level. Timepoint: Before the onset of cardiopulmonary bypass and during anesthesia, 5 minutes, 30 minutes and one hour after the onset of cardiopulmonary bypass. Method of measurement: Arterial blood sample and arterial gas analyzer.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The amount of sodium bicarbonate injected to correct acidosis. Timepoint: 5 minutes, 30 minutes and one hour after the start of the bypass. Method of measurement: observation.</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>Shahid Rajaee Cardiovascular Center Tehran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-03-04</approval_date>
        <contact_name>Ethic comittee of Shahid Rajai Cardiovascular Medical and Research Center</contact_name>
        <contact_address>Ayattollah Hashemi Highway, cross Vali-asr Ave.Shahid Rajai Cardiovascular, Medical and Research Heart Center Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
