<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/NCT03033706</url>
  </required_header>
  <id_info>
    <org_study_id>MD-4-2016</org_study_id>
    <nct_id>NCT03033706</nct_id>
  </id_info>
  <brief_title>Intraoperative Goal Directed Fluid Management in Supratentorial Brain Tumor Craniotomy</brief_title>
  <official_title>Intraoperative Goal Directed Fluid Management Guided by Pulse Pressure Variation in Supratentorial Brain Tumor Craniotomy: a Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients&#xD;
      undergoing supratentorial mass excision. The investigators hypothesize that in these&#xD;
      procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient&#xD;
      hemodynamics intra and postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics,&#xD;
      and prolonged operative time. The role of fluid therapy in these patients is very critical,&#xD;
      hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased&#xD;
      intracranial tension. All these factors make fluid management in these procedures complex and&#xD;
      challenging. Evidence on the optimum protocol for intraoperative fluid management in&#xD;
      neurosurgical patients is still lacking.&#xD;
&#xD;
      Goal-directed therapy (GDT) in the operating room is a term used to describe the use of&#xD;
      cardiac output or similar parameters to guide intravenous fluid and inotropic therapy.&#xD;
&#xD;
      Although GDT was well reported in many procedures, its benefit in neurosurgical operations is&#xD;
      not well studied.&#xD;
&#xD;
      Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is&#xD;
      simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse&#xD;
      pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in&#xD;
      major abdominal surgery with good performance.&#xD;
&#xD;
      The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV&#xD;
      to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision.&#xD;
      The investigators hypothesize that in these procedures GDT might improve brain relaxation,&#xD;
      and patient hemodynamics intra and postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2017</start_date>
  <completion_date type="Actual">January 30, 2018</completion_date>
  <primary_completion_date type="Actual">January 25, 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>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of brain relaxation</measure>
    <time_frame>one minute after dural puncture and one minute before dural closure</time_frame>
    <description>A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>volume of intraoperative fluid requirements</measure>
    <time_frame>intraoperatively</time_frame>
    <description>in litres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output</measure>
    <time_frame>intraoperatively</time_frame>
    <description>Litres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>intraoperatively</time_frame>
    <description>in beat per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of episodes of hypotension</measure>
    <time_frame>intraoperatively</time_frame>
    <description>number of times where the blood pressure decreased by 25% of baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial blood gases</measure>
    <time_frame>one hour postoperatively</time_frame>
    <description>partial pressure of oxygen and carbon dioxide</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum lactate</measure>
    <time_frame>one hour postoperatively</time_frame>
    <description>in mmol per decilitre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin concentration</measure>
    <time_frame>one hour postoperatively</time_frame>
    <description>in grams per decilitre</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>prothrombin concentration</measure>
    <time_frame>one hour postoperatively</time_frame>
    <description>in percent</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Brain Tumor</condition>
  <condition>Craniotomy</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation guided fluid therapy): Study group will receive restricted fluid management with 1 ml/Kg/hr with concomitant PPV monitoring. PPV will be measured using invasive blood pressure monitor. Fluid bolus of 3 ml/Kg of ringer solution will be administrated whenever PPV is higher than 13%.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Brain tumor excision under general anesthesia. Intervention (Traditional fluid therapy): Control Group will receive standard fluid management of 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulse pressure variation guided fluid therapy</intervention_name>
    <description>Pulse pressure variation obtained from invasive blood pressure waveform</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional fluid therapy</intervention_name>
    <description>4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brain tumor excision</intervention_name>
    <description>Brain tumor excision under general anesthesia</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for supratentorial mass excision will be enrolled in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with arrhythmias, pulmonary hypertension, impaired cardiac contractility,&#xD;
             impaired liver or kidney function, and patients with BMI above 40 will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Mukhtar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Head of research committee section in anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hasanin</investigator_full_name>
    <investigator_title>Lecturer of anesthesia and critical care medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_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/NCT03033706
org study id: MD-4-2016
nct id: NCT03033706
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pulse pressure variation (PPV) to standard fluid management (4ml/Kg/hr) in patients
      undergoing supratentorial mass excision. The investigators hypothesize that in these
      procedures, goal-directed fluid therapy (GDT) might improve brain relaxation, and patient
      hemodynamics intra and postoperatively.
Neurosurgical operations are characterized by major fluid shift, frequent use of diuretics,
      and prolonged operative time. The role of fluid therapy in these patients is very critical,
      hypovolemia might lead to brain hypoperfusion and over-transfusion might lead increased
      intracranial tension. All these factors make fluid management in these procedures complex and
      challenging. Evidence on the optimum protocol for intraoperative fluid management in
      neurosurgical patients is still lacking.

      Goal-directed therapy (GDT) in the operating room is a term used to describe the use of
      cardiac output or similar parameters to guide intravenous fluid and inotropic therapy.

      Although GDT was well reported in many procedures, its benefit in neurosurgical operations is
      not well studied.

      Pulse pressure variation (PPV) is a famous dynamic method of fluid responsiveness. PPV is
      simply calculated by dividing the largest pulse pressure (PPmax - PPmin) by the average pulse
      pressure (PPmax + PPmin /2) and expressed as percentage. PPV was previously used in GDT in
      major abdominal surgery with good performance.

      The aim of this study is to compare the restricted fluid approach (1 ml/Kg/hr) guided by PPV
      to standard fluid management (4ml/Kg/hr) in patients undergoing supratentorial mass excision.
      The investigators hypothesize that in these procedures GDT might improve brain relaxation,
      and patient hemodynamics intra and postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Evaluation of brain relaxation
time frame: one minute after dural puncture and one minute before dural closure
description: A 4-point scale will be performed as follows: grade 1, perfectly relaxed; grade 2, satisfactorily relaxed; grade 3, firm brain; grade 4, bulging brain.
measure: volume of intraoperative fluid requirements
time frame: intraoperatively
description: in litres
measure: Urine output
time frame: intraoperatively
description: Litres
measure: heart rate
time frame: intraoperatively
description: in beat per minute
measure: number of episodes of hypotension
time frame: intraoperatively
description: number of times where the blood pressure decreased by 25% of baseline
measure: arterial blood gases
time frame: one hour postoperatively
description: partial pressure of oxygen and carbon dioxide
measure: serum lactate
time frame: one hour postoperatively
description: in mmol per decilitre
measure: Hemoglobin concentration
time frame: one hour postoperatively
description: in grams per decilitre
measure: prothrombin concentration
time frame: one hour postoperatively
description: in percent
arm group label: Study group
arm group type: Active Comparator
description: Brain tumor excision under general anesthesia. Intervention (Pulse pressure variation guided fluid therapy): Study group will receive restricted fluid management with 1 ml/Kg/hr with concomitant PPV monitoring. PPV will be measured using invasive blood pressure monitor. Fluid bolus of 3 ml/Kg of ringer solution will be administrated whenever PPV is higher than 13%.
arm group label: Control group
arm group type: Placebo Comparator
description: Brain tumor excision under general anesthesia. Intervention (Traditional fluid therapy): Control Group will receive standard fluid management of 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.
intervention type: Procedure
intervention name: Pulse pressure variation guided fluid therapy
description: Pulse pressure variation obtained from invasive blood pressure waveform
arm group label: Study group
intervention type: Procedure
intervention name: Traditional fluid therapy
description: 4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.
arm group label: Control group
intervention type: Procedure
intervention name: Brain tumor excision
description: Brain tumor excision under general anesthesia
arm group label: Control group
arm group label: Study group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ahmed Mukhtar, Professor
role: Study Director
affiliation: Head of research committee section in anesthesia department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Lecturer of anesthesia and critical care medicine
mesh term: Brain Neoplasms
sharing ipd: No