<?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>IRCT20090701002112N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-10-04</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>Determination of the Preventive Effect of Desmopressin Acetate on the incidence of bleeding complications following kidney biopsy in patients with renal disease</public_title>
      <acronym></acronym>
      <scientific_title>Determination of the Preventive Effect of Desmopressin Acetate on the incidence of bleeding complications following kidney biopsy in patients with renal disease</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>146</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1735</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Patients were divided into two groups A and B. Block randomization methods were used. The size of the block was four and in each block 2 patient in group A and 2 patient in group B were assigned. The order of groups A and B within each block was determined randomly using function (RAND) in Excel software, Blinding description: Patients and the interventionist and the person examining the results did not know what group the individuals were in, and the study would be double blind.</study_design>
      <phase>2</phase>
      <hc_freetext>Chronic kidney patients.</hc_freetext>
      <i_freetext>Intervention 1: Based on the block of redundancy and the patient in the intervention group, 1 hour before biopsy, desmopressin acetate is received in the nose and 1 kg / kg. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl. Intervention 2: Based on the rate of redundancy and the fact that the patient is in the control group, 1 hour before biopsy, 0.6 kg / kg sodium chloride receives intranasal. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl.</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 haven't decided yet - the release schedule is still unknown</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Ali Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University of Medical Sciences, olestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3373 8383</telephone>
        <email>ghorbani-a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Ali Ghorbani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Jundishapur University of Medical Sciences,  Golestan Blvd.</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3374 3013</telephone>
        <email>ghorbani-a@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People 18 years and older
15≤GFR≤90 cc/min/1.73 m2 according MDRD formula</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Disrupted coagulation profile (including disruption in any of the PT tests, INR, PTT, and platelet counts are less than 50000
Systrelic Blood Pressure Time Biopsy less than160mmhg
Diastolic BP Time to do biopsy less than100mmhg
Single kidney
Kidney cancer
Renal hydronephrosis
Renal Pyrenophore
Small size Significant kidneys in ultrasound
Severe obesity
Hemoglobin less than 11
Sodium concentration in serum less than 120
Primary phenotypes
Renal transplantation
Multiple cysts in both kidneys</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N18.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic kidney disease, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Based on the block of redundancy and the patient in the intervention group, 1 hour before biopsy, desmopressin acetate is received in the nose and 1 kg / kg. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl</i_keyword>
      <i_keyword>Based on the rate of redundancy and the fact that the patient is in the control group, 1 hour before biopsy, 0.6 kg / kg sodium chloride receives intranasal. After 1 hour, the ultrasound ultrasound radiologist will perform ultrasound with supine and needl</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Hematoma. Timepoint: Immediately after receiving a kidney biopsy specimen and 24 hours later, and in the event of a hematoma, 48-72 hours later. Method of measurement: Ultrasonography.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Hematuria. Timepoint: After biopsy. Method of measurement: View at any time urinating.</sec_outcome>
      <sec_outcome>Vital signs l (blood pressure and heart rate). Timepoint: Every 15 minutes for 2 hours, then every 1 hour for 4 hours, then every 2 hours for 6 hours, and then every 4 hours. Method of measurement: Device.</sec_outcome>
      <sec_outcome>Flank pain. Timepoint: Follow up on every visit. Method of measurement: Physical exam.</sec_outcome>
      <sec_outcome>Biochemical Factors (Sodium, Hemoglobin, Hematocrit). Timepoint: 24 hours after biopsy. Method of measurement: Blood test.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2010-08-20</approval_date>
        <contact_name>Ethics committee of Ahwaz Jundishapur University of Medical Sciences (AJUMS)</contact_name>
        <contact_address>Ahvaz Jndishapour University of Medical Sciences,  Golestan blvd. Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
