<?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>IRCT20211101052940N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-02-05</date_registration>
      <primary_sponsor>Shahid Rajaei Cardiovascular Hospital</primary_sponsor>
      <public_title>The effect of moderate acidification of arterial blood pH by controlled inhalation of carbon dioxide on the rate of reperfusion injury in the early minutes after 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 by controlled inhalation of carbon dioxide on the rate of reperfusion injury in the early minutes after aortic clamp opening during heart valve surgery: A Pilot Study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60002</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: Patients are divided into two groups of 30 based on randomized block size 4.
A list of how patients are crashed into a closed envelope is provided to the researcher and patients are assigned to each of the intervention and control groups before the aortic clamp is opened.
Performed by the researcher, 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, 6 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 this group of patients, reperfusion will be performed with normal pH, ie between 7.35 and 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 7753 3097</telephone>
        <email>aregnia_minasians@yahoo.com</email>
        <affiliation>Shahid Rajaie cardiovascular, medical and research center</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Doctor Seyed Saeed Hosseini</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>0098 21 23921        داخلی:2193</telephone>
        <email>saeid.hosseini@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>I38</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Endocarditis, valve unspecified</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, 6 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 this group of patients, reperfusion will be performed with normal pH, ie between 7.35 and 7.45.</i_keyword>
    </intervention_keyword>
    <primary_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: Minutes.</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>Consumption of inotropic after opening the aortic clamp. Timepoint: After removal of the aortic clamp. Method of measurement: Micrograms per kilogram per hour.</prim_outcome>
      <prim_outcome>Requires defibrillator. Timepoint: After removal of the aortic clamp. Method of measurement: Yes or no.</prim_outcome>
      <prim_outcome>Need a pacemaker. 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>Heart ejection fraction. Timepoint: Before and after surgery. Method of measurement: Echo of the heart and in percent.</prim_outcome>
      <prim_outcome>Glutathione peroxidase and superoxide dismutase enzymes. 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 liter.</prim_outcome>
      <prim_outcome>Malonyl di aldehyde. Timepoint: Before the aortic clamp and 5 minutes after the opening of the aortic clamp from the coronary sinus. Method of measurement: Micromol per deciliter.</prim_outcome>
      <prim_outcome>Nitric oxide. Timepoint: Before the aortic clamp and 5 minutes after the opening of the aortic clamp from the coronary sinus. Method of measurement: Micromol per deciliter.</prim_outcome>
      <prim_outcome>Duration of mechanical ventilation. Timepoint: Duration of the patient's arrivalafter surgery to the intensive care unit. Method of measurement: Hour.</prim_outcome>
      <prim_outcome>Stay in the intensive care unit. Timepoint: Duration of the patient arrival after surgery to the intensive care unit until to get out of it. Method of measurement: Hour.</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>2021-09-08</approval_date>
        <contact_name>Ethics committee of Rajaie cardiovascular, medical and research center</contact_name>
        <contact_address>Bell 7, No. 14, Shahid Javadnia St, Bahar Shiraz St, 7th Tir Square Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
