<?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>IRCT20150606022569N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-26</date_registration>
      <primary_sponsor>Bojnourd University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of DHA serum in the treatment of aluminum phosphide poisoning</public_title>
      <acronym></acronym>
      <scientific_title>Determining the effectiveness of Dihydroxyacetone (DHA) serum in the treatment of patients with aluminum phosphide (rice tablet) poisoning by assessing the blood pressure and ECG changes and cardiac function</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-11-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>10</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/69575</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: A Prospective Pre-Post Study.</study_design>
      <phase>2</phase>
      <hc_freetext>Poisoning with rice tablets (aluminum phosphide).</hc_freetext>
      <i_freetext>Intervention group: The dihydroxyacetone (DHA) serum for injection, which is prepared in 500 cc bottles of 5% dextrose water at Shiraz University of Medical Sciences, is given intravenously to the patient who meets the inclusion criteria at a rate of 500 cc (one bottle) per hour. If the patient tolerates it and there are no life-threatening complications, the second and third 500 cc are administered. If needed, up to the maximum total volume of 2500 cc is infused for them..</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Bagher Oghazian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9414974877</zip>
        <telephone>+98 58 3151 0000</telephone>
        <email>mohammadbagher_oghazian@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Leila Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd</address>
        <city>Bojnurd</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9414974877</zip>
        <telephone>+98 58 3151 0000</telephone>
        <email>Hosseini1115@yahoo.com</email>
        <affiliation>Bojnourd University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>This study is conducted on people who have been poisoned (intentionally or unintentionally) with aluminum phosphide (rice tablets).</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The rice tablet(s) is/are exceeded their expiration date.
The tablet(s) is/are exposed to moisture and release(s) its/their phosphine gas.
The tablet(s) is/are dissolved in water prior to use and so release(s) its/their phosphine gas.
The tablet(s) is/are thoroughly crushed before use, resulting in a large amount of phosphine gas being released.
The tablet(s) and its/their contents are thrown out immediately after eating due to vomiting.
The person ingested the "Banan tablet" (a tablet that contains garlic, salt and starch, and is sometimes erroneously referred to as the rice tablet in Iran).</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>T60.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Toxic effect of rodenticides</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The dihydroxyacetone (DHA) serum for injection, which is prepared in 500 cc bottles of 5% dextrose water at Shiraz University of Medical Sciences, is given intravenously to the patient who meets the inclusion criteria at a rate of 500 cc (one bottle) per hour. If the patient tolerates it and there are no life-threatening complications, the second and third 500 cc are administered. If needed, up to the maximum total volume of 2500 cc is infused for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Changes in blood pressure. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Blood pressure monitor.</prim_outcome>
      <prim_outcome>Electrocardiogram (ECG) changes. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Electrocardiography.</prim_outcome>
      <prim_outcome>Contractile strength of the heart by measuring EF. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Echocardiography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Arterial oxygen saturation. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Measurement of arterial oxygen saturation.</sec_outcome>
      <sec_outcome>Blood glucose. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Laboratory measurement of blood glucose.</sec_outcome>
      <sec_outcome>Level of consciousness. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Using the Glasgow Coma Scale (GCS).</sec_outcome>
      <sec_outcome>Mortality rate. Timepoint: End of the study. Method of measurement: Number of patients who died.</sec_outcome>
      <sec_outcome>Incidence of adverse effects. Timepoint: During and following the administration of DHA until the death or hospital discharge. Method of measurement: Incidence of the adverse effect following DHA injection.</sec_outcome>
      <sec_outcome>Arterial blood acidity. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Measurement of arterial blood pH.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: At predetermined intervals prior to and following the administration of DHA until the death or hospital discharge. Method of measurement: Heart rate monitor.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Shiraz University of Medical Sciences</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Bojnourd University of Medical Sciences</source_name>
      <source_name>Hossein Niknahad</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-22</approval_date>
        <contact_name>North Khorasan University of Medical Sciences</contact_name>
        <contact_address>Dolat Blvd., Central Building of North Khorasan University of Medical Sciences, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
