<?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>IRCT20100228003449N33</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-11</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Magnesium sulfate and reducing sedative requirement</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of magnesium sulfate efficacy in reducing sedative requirement in patients under mechanical ventilation</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-12-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80452</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by the method of random blocks. According to the sample size, four patients are included in each block. Random groups are AABB, BBAA, ABBA, ABAB, BABA, BAAB. Random numbers will be generated by Excel software, Blinding description: Intravenous magnesium sulfate and saline will be prepared and labeled by a technician not involved in the study. The patient and research members are unaware of the contents of the syringes.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Management of pain, agitation/sedation and delirium in mechanically ventilated patients.</hc_freetext>
      <i_freetext>Intervention 1: Control group: In addition to the sedation protocol, patients will receive placebo (saline). Intervention 2: Intervention group: In addition to the sedation protocol, patients will receive intravenous magnesium sulfate. The target serum level of magnesium in this group is 3 mg/dL. The dose of magnesium for each patient will be calculated based on the rule of thumb. According to this rule, every 1 gram of magnesium sulfate leads to an increase of 0.18 mg/dL in the serum level of magnesium. One third of the calculated dose will be infused as a bolus within 30 minutes and the rest within 24 hours. Each 1 gram of intravenous magnesium sulfate will be diluted in 50 ml of normal saline and infused at least within 1 hour.</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>Hossein Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1427614411</zip>
        <telephone>+98 21 6695 4715</telephone>
        <email>khalilih@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Khalili</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1417614411</zip>
        <telephone>+98 21 6695 4715</telephone>
        <email>khalilih@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients in ICU who required mechanical ventilation for at least 48 hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with a history of allergic reactions to intravenous magnesium sulfate
Patients who need deep sedation (RASS≥-4)
Patients with any brain damage
Patients with myasthenia gravis
Patients with chronic renal failure (eGFR less than 30 ml/min)
Pregnant and lactating women</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F13</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Sedative, hypnotic, or anxiolytic related disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: In addition to the sedation protocol, patients will receive placebo (saline).</i_keyword>
      <i_keyword>Intervention group: In addition to the sedation protocol, patients will receive intravenous magnesium sulfate. The target serum level of magnesium in this group is 3 mg/dL. The dose of magnesium for each patient will be calculated based on the rule of thumb. According to this rule, every 1 gram of magnesium sulfate leads to an increase of 0.18 mg/dL in the serum level of magnesium. One third of the calculated dose will be infused as a bolus within 30 minutes and the rest within 24 hours. Each 1 gram of intravenous magnesium sulfate will be diluted in 50 ml of normal saline and infused at least within 1 hour.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Cumulative dose of required intravenous opioid. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on fentanyl dose or equivalent dose of other registered opioids.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Required adjuvant sedative drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.</sec_outcome>
      <sec_outcome>Required analgesic drugs. Timepoint: At the end of 24 and 48 hours. Method of measurement: Based on the registered drug and cumulative dosage.</sec_outcome>
      <sec_outcome>Duration of respiratory support. Timepoint: Daily. Method of measurement: Patient follow-up.</sec_outcome>
      <sec_outcome>Duration of ICU stay. Timepoint: Daily. Method of measurement: Patient follow-up.</sec_outcome>
      <sec_outcome>28-day mortality. Timepoint: 28 days after starting the intervention. Method of measurement: Patient follow-up.</sec_outcome>
      <sec_outcome>Safety of intravenous magnesium sulfate. Timepoint: Continuous monitoring during the study period. Method of measurement: Patient follow-up.</sec_outcome>
      <sec_outcome>Change in serum CRP level. Timepoint: 48 hours after starting the intervention. Method of measurement: Laboratory data.</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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-10-27</approval_date>
        <contact_name>Ethics Committee of Tehran University Of Medical Sciences</contact_name>
        <contact_address>Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
