<?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>IRCT20170903036041N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-16</date_registration>
      <primary_sponsor>Vice chancellery for research Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of Effectiveness of Different Dosage of Neostigmine in Combination with Metoclopramide, on Gastric Residual Volume</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of Effectiveness of Different Dosage of Neostigmine in Combination with Metoclopramide, on Gastric Residual Volume, in Enteral Nutrition, in Hospitalized Patients in Intensive Care Unit</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>165</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27067</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Traumatized patients divided into three groups A, B and C using block randomized method. In this study a person who is not in the study process after the admission of the patient, allocated the relevant intervention to each patient with the relevant block and notifies the director of the research team, Blinding description: This is a double blind study that patients or their companions after verifying the informed consent of the study, will be blind the type of intervention. Physicians and carers of patients which examines the clinical status of patients will be blind to the type of intervention that patients are taking.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Gastric residual volume.</hc_freetext>
      <i_freetext>Intervention 1: (Gold standard group): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one milligram of Neostigminedose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minut. Intervention 2: (Intervention group 2): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, two milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 mi. Intervention 3: (Intervention group 1): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one and a half milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in.</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></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Omid Moradi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 912 124 4560</telephone>
        <email>moradimoghadam.o@iums.ac.ir</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Omid Moradi Moghadam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences, Hemmat Highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۴۴۹۶۱۴۵۳۵</zip>
        <telephone>+98 21 6653 9255</telephone>
        <email>moradimoghadam.o@iums.ac.ir</email>
        <affiliation>Iran University of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Enteral nutrition feeding
After three hours from the last gavage gastric residual volume ≥50%
Age 18-60</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Diabetes mellitus disease
Atrioventricular block
Heart rate &lt;60
Systolic blood pressure &lt;90
Within 10 days Gastrointestinal surgery
Clinical signs of Gastrointestinal obstruction
Bronchospasm or Asthma history
In 24 hours administration of Prokinetic drugs
Sensitivity to Metoclopramide or Neostigmine
Kidney failure or Creatinine &gt;2 milligram/deciliter
Hypokalemia
Concomitant medication with Cyclosporine
Digoxin and Monoamine Oxidase inhibitors</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>(Gold standard group): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one milligram of Neostigminedose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 minut</i_keyword>
      <i_keyword>(Intervention group 2): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, two milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in time 60 mi</i_keyword>
      <i_keyword>(Intervention group 1): Metoclopramide will be prescribed five milligrams in every eight hours by IV.slow method during one minute. In addition, one and a half milligrams of Neostigmine dose in dilute solution of 100 cc Normal Saline and infusion takes in</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Gastric residual volume. Timepoint: three hours after the completion of the infusion. Method of measurement: Cc.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Age. Timepoint: At the time of entering the study. Method of measurement: Chronological age.</sec_outcome>
      <sec_outcome>Blood pressure. Timepoint: Recorded during the measurement of the gastric remaining volume. Method of measurement: mmHg (millimeters of mercury).</sec_outcome>
      <sec_outcome>Respiratory rate. Timepoint: Recorded during the measurement of the gastric remaining volume. Method of measurement: The number of movements indicative of inspiration and expiration per unit time.</sec_outcome>
      <sec_outcome>Heart rate. Timepoint: Recorded during the measurement of the Gastric remaining volume. Method of measurement: Number of contractions of the heart per minute (bpm).</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 research Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-03</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Science</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
