<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/NCT03780686</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH3206/17</org_study_id>
    <nct_id>NCT03780686</nct_id>
  </id_info>
  <brief_title>Dopamine and Norepinephrine Infusion With Restricted Hydration</brief_title>
  <official_title>The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to assess the effect of adding dopamine infusion in addition to&#xD;
      restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate&#xD;
      levels as an indicator for tissue hypo perfusion and renal function in comparison to&#xD;
      restrictive hydration combined with noradrenaline infusion only and standard hydration during&#xD;
      open abdominal surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred and twenty patients were randomly assigned into three groups (dopamine&#xD;
      norepinephrine group, restrictive hydration group and liberal hydration group) undergoing&#xD;
      open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group&#xD;
      (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the&#xD;
      surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution&#xD;
      until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids&#xD;
      until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was&#xD;
      introduced according to maintenance, deficit for the first 3 hours (hours fasting x body&#xD;
      weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).&#xD;
&#xD;
      The outcome to be assessed was serial measurements of serum lactate intraoperatively and&#xD;
      immediate postoperatively as an index of tissue perfusion, in addition to blood pressure,&#xD;
      heart rate and oxygen saturation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2017</start_date>
  <completion_date type="Actual">December 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 20, 2018</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in serum lactate level</measure>
    <time_frame>Before induction of anesthesia and up to 12 hours after.</time_frame>
    <description>Serum lactate level in mmol/l</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in renal function test</measure>
    <time_frame>Before induction of anesthesia and up to 12 hours after.</time_frame>
    <description>Measuring creatinine level</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Renal Function Test, Urine Output, Lactate Level</condition>
  <arm_group>
    <arm_group_label>Dopamine and norepinephrine infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Norepinephrine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infusion norepinephrine (3mcg/kg/h) with restricted fluid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard fluid management</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard fluid managements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine, dopamine</intervention_name>
    <description>drugs to decrease bleeding</description>
    <arm_group_label>Dopamine and norepinephrine infusion</arm_group_label>
    <arm_group_label>Norepinephrine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with American Society of Anesthesiologists (ASA) physical status I or II&#xD;
&#xD;
          -  Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy&#xD;
             were contained in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with coagulopathies,&#xD;
&#xD;
          -  Hepatic dysfunction (prothrombin ratio &lt;50%),&#xD;
&#xD;
          -  Renal dysfunction,&#xD;
&#xD;
          -  Congestive heart failure (New York Heart Association scores ≥3),&#xD;
&#xD;
          -  Contraindications for epidural analgesia (e.g. patient refusal, local infection or&#xD;
             coagulopathy), and peripheral vascular disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>11233</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Restrictive hydration,</keyword>
  <keyword>Dopamine,</keyword>
  <keyword>Norepinephrine,</keyword>
  <keyword>Serum lactate,</keyword>
  <keyword>Standard hydration</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03780686
org study id: ASUH3206/17
nct id: NCT03780686
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study was designed to assess the effect of adding dopamine infusion in addition to
      restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate
      levels as an indicator for tissue hypo perfusion and renal function in comparison to
      restrictive hydration combined with noradrenaline infusion only and standard hydration during
      open abdominal surgeries.
One hundred and twenty patients were randomly assigned into three groups (dopamine
      norepinephrine group, restrictive hydration group and liberal hydration group) undergoing
      open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group
      (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the
      surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution
      until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids
      until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was
      introduced according to maintenance, deficit for the first 3 hours (hours fasting x body
      weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

      The outcome to be assessed was serial measurements of serum lactate intraoperatively and
      immediate postoperatively as an index of tissue perfusion, in addition to blood pressure,
      heart rate and oxygen saturation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: Changes in serum lactate level
time frame: Before induction of anesthesia and up to 12 hours after.
description: Serum lactate level in mmol/l
measure: Changes in renal function test
time frame: Before induction of anesthesia and up to 12 hours after.
description: Measuring creatinine level
arm group label: Dopamine and norepinephrine infusion
arm group type: Active Comparator
description: Infusion doppamine (2-5mcg/kg/min) and norepinephrine (3mcg/kg/h) with restricted fluid
arm group label: Norepinephrine
arm group type: Active Comparator
description: Infusion norepinephrine (3mcg/kg/h) with restricted fluid.
arm group label: Standard fluid management
arm group type: No Intervention
description: Standard fluid managements.
intervention type: Drug
intervention name: Norepinephrine, dopamine
description: drugs to decrease bleeding
arm group label: Dopamine and norepinephrine infusion
arm group label: Norepinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor
mesh term: Dopamine
mesh term: Norepinephrine
sharing ipd: No