<?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>IRCT20231022059804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-27</date_registration>
      <primary_sponsor>Semnan University of Medical Sciences</primary_sponsor>
      <public_title>Assessment of the effect of high flow of cardiopulmonary pump on the laboratory findings and cerebral perfusion in patients undergo open heart surgery</public_title>
      <acronym></acronym>
      <scientific_title>Clinical Trial of Assessment of the effect of high flow of cardiopulmonary pump on the laboratory findings and cerebral perfusion in patients undergo open heart surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73320</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: From the start date of the project eligible patients entered the study, these patients are randomly divided into two groups. Randomization is done using a table of random numbers. One group receives normal and standard flow and the other group receives high flow.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: Open Heart Surgery using cardiopulmonary pump. Condition 2: Coronary artery bypass grafting.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: High flow group: In this group of patients, a flow rate of 2.6 liters per square meter per minute is used. Intervention 2: Control group: Normal flow group: In this group, a flow rate of 2.4 liters per square meter per minute is used to establish the flow of the cardiopulmonary pump, which is the usual flow rate used during open heart 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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the lack of similar studies and the novelty of the proposed topic, it is considered that until the samples and data analysis are completed, and also because of the wide range  of variables, no decision should be made regarding the publication.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Muhamad Frouzeshfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Kowsar Hospital, Golestan Town</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3142 0000</telephone>
        <email>mff45@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Muhamad Frouzeshfard</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Anesthesiology Department, Kowsar Hospital, Golestan Town</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3519899951</zip>
        <telephone>+98 23 3142 0000</telephone>
        <email>mff45@yahoo.com</email>
        <affiliation>Semnan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Admission in the Open Heart ICU of Kowsar hospital
Candidate for undergoing open heart surgery
Obtaining a written consent for entering to the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with EF under 30%
Patients who need Intra-aortic balloon pump
Any unpredictable event during the surgery or Malfunction of Cardiopulmonary pump
Aorta clamping lasts more than 2 hours
The whole surgery lasts more than 3 hours
Patients with history of CVA
Patients with Congestive Heart Failure
Patients with the history of chronic kidney disease and undergoing dialysis
Patients with the history of chronic renal failure or undergoing hemodialysis
Due to the fact that during the surgery the amount of PFR changes depending on the conditions of the operation, in case of fluctuation, the PFR may reach a level that reaches another group</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>I97.820</hc_code>
      <hc_code>I25.719</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural cerebrovascular infarction during cardiac surgery</hc_keyword>
      <hc_keyword>Atherosclerosis of autologous vein coronary artery bypass graft(s) with unspecified angina pectoris</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: High flow group: In this group of patients, a flow rate of 2.6 liters per square meter per minute is used.</i_keyword>
      <i_keyword>Control group: Normal flow group: In this group, a flow rate of 2.4 liters per square meter per minute is used to establish the flow of the cardiopulmonary pump, which is the usual flow rate used during open heart surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Blood Urea Nitrogen. Timepoint: 1 day before and 1 day after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>Serum Creatinine. Timepoint: 1 day before and 1 day after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>Alkaline phosphatase serum level. Timepoint: 1 day before and 1 day after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>Aspartate aminotransferase serum level. Timepoint: 1 day before and 1 day after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>Alanine transaminase serum level. Timepoint: 1 day before and 1 day after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>The consciousness level of patient. Timepoint: Before surgery in OR and after surgery in recovery room. Method of measurement: The consciousness level of patient, which is evaluated by anesthesiologist in 4 levels. 1.Patient is alert: the patient is awake with his eyes open and answers the questions. It doesn't matter if the answers are imprecise or incorrect. 2. Responds to the Verbal stimulus: the patient only uses unintelligible sounds in answering the questions. 3. Responds to the pain stimulus: the patient only responds to pain. This response is either associated with the removal of the pain agent or only with stretching and expansion in the limbs. 4. No response: The patient is without any response to sound and pain.</prim_outcome>
      <prim_outcome>Cerebral Oxygenation. Timepoint: During surgery. Method of measurement: Cerebral Oximeter.</prim_outcome>
      <prim_outcome>Serum electrolytes level (Sodium, potassium and calcium). Timepoint: Before , during(every 30 minutes) and after surgery. Method of measurement: Blood sample test.</prim_outcome>
      <prim_outcome>Serum Lactate Level. Timepoint: Before , during(every 30 minutes) and after surgery. Method of measurement: Blood sample test.</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>Semnan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-27</approval_date>
        <contact_name>Ethics committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Kpwsar educational research and treatment center, Golestan Town, Semnan, Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
