<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444089</url>
  </required_header>
  <id_info>
    <org_study_id>N-1 / 2020</org_study_id>
    <nct_id>NCT04444089</nct_id>
  </id_info>
  <brief_title>Perioperative Fluid Therapy in Pediatric Patients Undergoing Penile Hypospadias Repair</brief_title>
  <official_title>Role of Lung Ultrasound in Comparison of Different Fluid Replacement Regimens in Pediatric Patients Undergoing Penile Hypospadias Repair, Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optimization of perioperative fluid management is important for preventing adverse events,&#xD;
      such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult&#xD;
      and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric&#xD;
      patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is&#xD;
      important during and after induction of general anesthesia (GA).The aim of this study is to&#xD;
      investigate the difference between conventional and restrictive fluid replacement regimens&#xD;
      using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a&#xD;
      surgery with minor fluid loss.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2019</start_date>
  <completion_date type="Actual">February 25, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>volume overload using lung ultrasound</measure>
    <time_frame>intraoperative duration that is approximately 110 minutes.</time_frame>
    <description>volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Volume Overload</condition>
  <arm_group>
    <arm_group_label>conventional group, CG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>receives Ringer's lactate solution at a rate of 4 ml/kg/h for the first-10 kg of body weight, 2 ml/kg/h for the second-10 kg of body weight, and 1 ml/kg/h for each further kg of body weight. The deficit volume is calculated as the maintenance volume multiplied by fasting hours and given as follows: 50% of the volume in the first hour, 25% of the volume in the second hour, and 25% of the volume in the third hour, in addition to the aforementioned maintenance volume</description>
  </arm_group>
  <arm_group>
    <arm_group_label>restricted group, RG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the RG receives Ringer's lactate solution at a rate of 3 ml/kg/h from the start to the end of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>lung ultrasound</intervention_name>
    <description>Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).</description>
    <arm_group_label>conventional group, CG</arm_group_label>
    <arm_group_label>restricted group, RG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for repair of penile hypospadias with American Society of&#xD;
             Anaesthesiologists' physical status of class I-II.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pulmonary, cardiovascular, or hematological disorders or a family&#xD;
             history of allergy to local anesthetics or lung disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Elsonbaty, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>anesthesia department at Cairo University</name>
      <address>
        <city>Cairo</city>
        <state>Elmanial</state>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>1. Joshua IS. Perioperative fluid restriction. Clin Colon Rectal Surg 2013;26:197-202. 2. Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, et al. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: Consensus statement for anaesthesia practice. Acta Anaesthesiol Scand 2016;60:289-334. 3. Varadhan KK, Lobo DN. A meta-analysis of randomised controlled trials of intravenous fluid therapy in major elective open abdominal surgery: Getting the balance right. Proc Nutr Soc 2010;69:488-9. 4. Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, et al. Effects of intraoperative fluid management on postoperative outcomes: A hospital registry study. Ann Surg 2018;267:1084-92.</citation>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 6, 2021</last_update_submitted>
  <last_update_submitted_qc>June 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sherif Abdullah Mohamed</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Conventional regimen</keyword>
  <keyword>restrictive regimen</keyword>
  <keyword>lactated Ringer's solution</keyword>
  <keyword>lung ultrasound</keyword>
  <keyword>fluid management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not to be shared</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444089
org study id: N-1 / 2020
nct id: NCT04444089
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Optimization of perioperative fluid management is important for preventing adverse events,
      such as hypovolemia, cardiogenic shock, volume overload, and pulmonary edema, in both adult
      and pediatric patients. If the intravascular (IV) fluid volume is not optimized, pediatric
      patients are at risk of dehydration or volume overload. Perioperative IV fluid therapy is
      important during and after induction of general anesthesia (GA).The aim of this study is to
      investigate the difference between conventional and restrictive fluid replacement regimens
      using lung ultrasound in pediatric patients undergoing penile hypospadias repair, as a
      surgery with minor fluid loss.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: volume overload using lung ultrasound
time frame: intraoperative duration that is approximately 110 minutes.
description: volume overload using lung ultrasound according to The mean number of B-lines detected on the ultrasound image
arm group label: conventional group, CG
arm group type: Experimental
description: receives Ringer's lactate solution at a rate of 4 ml/kg/h for the first-10 kg of body weight, 2 ml/kg/h for the second-10 kg of body weight, and 1 ml/kg/h for each further kg of body weight. The deficit volume is calculated as the maintenance volume multiplied by fasting hours and given as follows: 50% of the volume in the first hour, 25% of the volume in the second hour, and 25% of the volume in the third hour, in addition to the aforementioned maintenance volume
arm group label: restricted group, RG
arm group type: Experimental
description: Patients in the RG receives Ringer's lactate solution at a rate of 3 ml/kg/h from the start to the end of surgery.
intervention type: Diagnostic Test
intervention name: lung ultrasound
description: Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).
arm group label: conventional group, CG
arm group label: restricted group, RG
criteria: 
gender: All
minimum age: 3 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed Elsonbaty, M.D.
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
citation: 1. Joshua IS. Perioperative fluid restriction. Clin Colon Rectal Surg 2013;26:197-202. 2. Feldheiser A, Aziz O, Baldini G, Cox BP, Fearon KC, Feldman LS, et al. Enhanced Recovery After Surgery (ERAS) for gastrointestinal surgery, part 2: Consensus statement for anaesthesia practice. Acta Anaesthesiol Scand 2016;60:289-334. 3. Varadhan KK, Lobo DN. A meta-analysis of randomised controlled trials of intravenous fluid therapy in major elective open abdominal surgery: Getting the balance right. Proc Nutr Soc 2010;69:488-9. 4. Shin CH, Long DR, McLean D, Grabitz SD, Ladha K, Timm FP, et al. Effects of intraoperative fluid management on postoperative outcomes: A hospital registry study. Ann Surg 2018;267:1084-92.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sherif Abdullah Mohamed
investigator title: Principal investigator
mesh term: Hypospadias
sharing ipd: No
ipd description: not to be shared