<?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>IRCT20211101052940N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-04-14</date_registration>
      <primary_sponsor>Shahid Rajaei Cardiovascular Hospital</primary_sponsor>
      <public_title>The effect of moderate acidification of arterial blood pH on the rate of miR-499 Biomarker level in the early minutesafter aortic clamp opening during heart valve surgery: A Pilot Study</public_title>
      <acronym></acronym>
      <scientific_title>The effect of moderate acidification of arterial blood pH on the rate of miR-499 Biomarker level in the early minutes after aortic clamp opening during heart valve surgery: A Pilot Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66918</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients were divided into 2 groups of 30 people using the computer program CREATE A RANDOMISATION LIST, in the form of block randomization with a size of 4.
Thus, 15 blocks of 4 were obtained, and in each block, 2 patients were randomly assigned to the intervention group and 2 patients to the control group.
In each block, the permutations created were in the form of AABB, ABAB, ABBA, BBAA, ... where each A was the sign of the intervention group and the letter B was the sign of the control group, Blinding description: In this study, the intensive care unit nurse who is responsible for caring for the patient is kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of moderate arterial blood acidosis during reperfusion in valvular heart surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Temporary respiratory acidosis is induced for the reperfusion phase by intentional inhalation of Carbon dioxide gas into the oxygenator, and therapeutic hypercapnia (partial pressure of carbon dioxide = 50-60) is performed to establish a pH in the range of 7.25 to 7.30. In contrast, 5 minutes before reperfusion, gas is added to the mixture of oxygen and air, and after opening the aortic clamp, it continues for 2 minutes after reperfusion. Intervention 2: Control group: In the control group, blood re-perfusion to the heart is performed after opening the aortic clamp, with a pH in the normal range, i.e. 7.35 to 7.45.</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 Based on the consent obtained from patients, their information remains confidential.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aregnia Minasians</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 23921</telephone>
        <email>aregnia_minasians@yahoo.com</email>
        <affiliation>Shahid Rajaie cardiovascular, medical and research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aregnia Minasians</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Floor, operating room, corner of Niayesh, next to Mellat Park, Vali Asr St. (AS)</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1995614331</zip>
        <telephone>+98 21 7753 3097</telephone>
        <email>Aregnia_minasians@yahoo.com</email>
        <affiliation>Shahid Rajaei Cardiovascular Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient consent to study
Age over 18 years and under 65 years
No history of sternotomy and heart surgery
Left ventricular ejection fraction greater than 30%
Pulmonary outflow volume with pressure per second (FEV1) greater than 65% in spirometry
Hemoglobin above 10 mg per deciliter</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need for drug support (receiving inotropes before starting heart surgery)
Having a pacemaker or ICD(Implantable Cardioverter Defibrillator)
Having impaired lung function tests for FEV1 less than 40%
Having kidney or liver dysfunction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Temporary respiratory acidosis is induced for the reperfusion phase by intentional inhalation of Carbon dioxide gas into the oxygenator, and therapeutic hypercapnia (partial pressure of carbon dioxide = 50-60) is performed to establish a pH in the range of 7.25 to 7.30. In contrast, 5 minutes before reperfusion, gas is added to the mixture of oxygen and air, and after opening the aortic clamp, it continues for 2 minutes after reperfusion.</i_keyword>
      <i_keyword>Control group: In the control group, blood re-perfusion to the heart is performed after opening the aortic clamp, with a pH in the normal range, i.e. 7.35 to 7.45.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>MiR-499. Timepoint: Before the aortic clamp and 5 minutes after the opening of the aortic clamp from the coronary sinus. Method of measurement: coronary sinus blood samples in units per mili liter.</prim_outcome>
      <prim_outcome>Type of heart rhythm. Timepoint: After removal of the aortic clamp. Method of measurement: ECG curve shape and heart rate per minute.</prim_outcome>
      <prim_outcome>Return time of sinus rhythm of the heart. Timepoint: After removal of the aortic clamp. Method of measurement: seconds.</prim_outcome>
      <prim_outcome>Consumption of inotropic after opening the aortic clamp. Timepoint: After removal of the aortic clamp. Method of measurement: Yes or no.</prim_outcome>
      <prim_outcome>The amount of lactate. Timepoint: After separation of cardiopulmonary bypass machine. Method of measurement: Mg per liter.</prim_outcome>
      <prim_outcome>Cardiac enzymes (troponin, Lactate Dehydrogenase and Creatine kinase-MB levels). Timepoint: Before surgery, 12 and 24 hours after surgery. Method of measurement: Micrograms per deciliter.</prim_outcome>
      <prim_outcome>Need for antiarrhythmic drugs. Timepoint: After removal of the aortic clamp. Method of measurement: Yes or no.</prim_outcome>
      <prim_outcome>Heart ejection fraction. Timepoint: Before and after surgery. Method of measurement: Echo of the heart and in percent.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Blood pressure. Timepoint: During the injection of carbon dioxide. Method of measurement: Mm of mercury.</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 Rajaei Cardiovascular Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-31</approval_date>
        <contact_name>Ethics committee of Rajaie cardiovascular, medical and research center</contact_name>
        <contact_address>Next to Mellat Park, Vali Asr Ave, Tehran, IRAN. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
