<?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>IRCT201107217085N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-11-22</date_registration>
      <primary_sponsor>Vice Chancellery for Reserch and Technology, Isfahan University of Medical Sciences, Isfahan, Iran</primary_sponsor>
      <public_title>Noradrenalin versus Midodrin-Octerotid in Hepatorenal Syndrome</public_title>
      <acronym></acronym>
      <scientific_title>Noradrenalin versus the combination of Midodrine and Octreotide in the treatment of patients with Hepatorenal syndrome type 1 and 2 referred to Alzahra Hospital since 2011 to 2012</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>22</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/7509</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>Hepatorenal Syndrome type 1 &amp; 2.</hc_freetext>
      <i_freetext>Intervention 1: One group is treated with Noradrenalin infusion of 0.1 microgram per kilogram. The dose is escalated every 4 hours by 0.05 microgram per kilogram up to the maximum dose of 0.7 microgram per kilogram or until 10 millimeter increase in the mean arterial pressure. The drug is continued until creatinine is reached less than 1.5 milligram per deciliter or until 15 days. Intervention 2: The other group is treated with Octereotide infusion of 25 microgram per hour and oral Midodrin of 5 milligram three times a day up to the maximum dose of 45 milligram per day or until Mean arterial pressure is increased by 15 millimeter. The treatment is continued until creatinine is reached less than 1.5 milligram per deciliter or 15 days is elapsed.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Kambiz Yazdanpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alzahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1669 4894</telephone>
        <email>kyazdanpanah@resident.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Kambiz Yazdanpanah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Al-Zahra Hospital, Isfahan University of Medical Sciences, Soffeh Street, Isfahan, Iran</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8174673461</zip>
        <telephone>+98 31 1669 4894</telephone>
        <email>kyazdanpanah@resident.mui.ac.ir</email>
        <affiliation>Isfahan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Hepatorenal syndrom patients … Exclusion criteria: Improvement of renal function after volume expansion; history of infection, nephrotoxic drug usage or volume loss in recent week; contraindication to Noradrenalin, Midodrine or Octreotide; recent history of gastrointestinal bleeding; severe hepatic encephalopathy; hepatocellular carcinoma; platelet counts lower than 25000 per microliters; international normalized ratio (INR) more than 5; acute coronary syndrome</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K76.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Hepatorenal Syndrome</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>One group is treated with Noradrenalin infusion of 0.1 microgram per kilogram. The dose is escalated every 4 hours by 0.05 microgram per kilogram up to the maximum dose of 0.7 microgram per kilogram or until 10 millimeter increase in the mean arterial pressure. The drug is continued until creatinine is reached less than 1.5 milligram per deciliter or until 15 days.</i_keyword>
      <i_keyword>The other group is treated with Octereotide infusion of 25 microgram per hour and oral Midodrin of 5 milligram three times a day up to the maximum dose of 45 milligram per day or until Mean arterial pressure is increased by 15 millimeter. The treatment is continued until creatinine is reached less than 1.5 milligram per deciliter or 15 days is elapsed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Serum ceatinine. Timepoint: Before the study and every day during the study. Method of measurement: laboratory method.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Systolic and diastolic pressure. Timepoint: Before the study and every 4 hours during the study. Method of measurement: sphygmomanometer.</sec_outcome>
      <sec_outcome>Urinary output. Timepoint: Before the study and every day during the study. Method of measurement: Collecting scaled bag.</sec_outcome>
      <sec_outcome>Serum and urinary sodium. Timepoint: Before the study and every day during the study. Method of measurement: Laboratory method.</sec_outcome>
      <sec_outcome>Glomerular filtration rate. Timepoint: Before the study and every day during the study. Method of measurement: Cockroft-Gault formula.</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>Vice Chancellery for Reserch and Technology, Isfahan University of Medical Sciences, Isfahan, Iran</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-01</approval_date>
        <contact_name>Ethics committee, Isfahan University of Medical Sciences</contact_name>
        <contact_address>Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran Isfahan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
