<?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>IRCT20251013067605N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-10-19</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Dexmedetomidine on Acute Renal Injury Patients undergoing CABG</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effect of intraoperative dexmedetomidine infusion on acute renal failure in diabetic patients undergoing CABG surgery</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86781</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Blinding description: Despite of giving informed consent, participants are unaware of whether they are receiving the drug or placebo. Similarly, the outcome assessor only sees and notes the outcomes and he is unaware of whether the patient received the drug or placebo.</study_design>
      <phase>3</phase>
      <hc_freetext>Patients with diabetes treated with pills.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Dexmedetomidine (Medonex) diluted in saline at a concentration of 0.5 micrograms/kg/hour) In the placebo group, normal saline solution was administered via an infusion pump at the same rate and continued until the end of the surgery. Intervention 2: Control group: In the placebo group,0.9% normal saline solution was administered by infusion pump at a rate of 0.5 micrograms/kg/hour, starting at the beginning of surgery and continuing until the end of 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 I have not  decided yet, but if the data is requested by email to the corresponding author, the data will be made available to other researchers.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>DR.Mahdi Kahrom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahmad Abad Boulevard. Qaim Hospital (Aj)</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176697839</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>KahromMH@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Mehdi Kahrom</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ahmad Abad Boulevard. Qaim Hospital</address>
        <city>MASHHAD</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9176697839</zip>
        <telephone>+98 51 3840 0000</telephone>
        <email>KahromMH@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>EF&gt;35%
Diabetic patient treated with medication
Candidate for Elective CABG On-Pump beating with two or more grafts, provided that one of the grafts is the left internal mammary artery (LIMA)
HR &gt; 65 on arrival
GFR&gt;50
ASA Class II classification
Hct&gt;30%
The patient shouldn't have emergency surgery, concurrent valve surgery, or underlying renal, pulmonary, gastrointestinal, hepatic, or thyroid disease.
Age between 35 to 70</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reoperations and non-coronary procedures
CABG Off-Pump
Return to the operating room from the ICU
History of previous heart surgery
History of fever, trauma
Bilateral carotid artery stenosis &gt; 50%
Intubation difficult or takes longer than 20 seconds
BMI &gt; 30 kg/m²
HR&gt;65
LM&gt;50%
History of bundle branch block
History of treatment with clonidine or methyldopa
IABP</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N17.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Acute kidney failure, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Dexmedetomidine (Medonex) diluted in saline at a concentration of 0.5 micrograms/kg/hour) In the placebo group, normal saline solution was administered via an infusion pump at the same rate and continued until the end of the surgery.</i_keyword>
      <i_keyword>Control group: In the placebo group,0.9% normal saline solution was administered by infusion pump at a rate of 0.5 micrograms/kg/hour, starting at the beginning of surgery and continuing until the end of surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Incidence of postoperative AKI in diabetic patients undergoing CABG who received dexmedetomidine. Timepoint: The incidence of AKI is determined by measuring urea and creatinine before, during, and after surgery. Method of measurement: Blood test and urine output.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-11</approval_date>
        <contact_name>Imam Reza Hospital Educational, Research and Treatment Center - Mashhad University of Medical Scienc</contact_name>
        <contact_address>Ahmadabad Boulevard, Qaim Hospital (AJ) MASHHAD Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
