<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/NCT03249298</url>
  </required_header>
  <id_info>
    <org_study_id>OBKRGKOAIT216</org_study_id>
    <nct_id>NCT03249298</nct_id>
  </id_info>
  <brief_title>Fluid Optimization With Crystalloids and Colloids in Neurosurgery</brief_title>
  <acronym>KOKR</acronym>
  <official_title>Comparison of Crystaloids and Colloids for Fluid Optimization in Patients Undergoing Neurosurgical Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Centre Ljubljana</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</source>
  <brief_summary>
    <textblock>
      Fluid optimization in neurosurgical patients has an important impact on preservation of&#xD;
      cerebral perfusion pressure and minimization of cerebral oedema during and after the&#xD;
      craniotomy. The investigators would like to know if crystalloids or colloids are equally&#xD;
      useful for goal directed therapy in this patients. The investigators will record haemodynamic&#xD;
      stability, volume loading and postoperative complications and compare two groups of patients.&#xD;
      One group will be optimised with crystalloids and the second with colloids. The investigators&#xD;
      will compare also hospital stay and mortality in the two groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in&#xD;
      neurosurgical patients. Fluid management includes maintenance of intravascular volume,&#xD;
      preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid&#xD;
      management of the neurosurgical patient has advanced from &quot;run them dry&quot; to &quot;run them&#xD;
      isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by&#xD;
      current strategies are still unknown. Advanced techniques provide goal directed fluid therapy&#xD;
      which is currently the gold standard in fluid strategy. In patients undergoing craniotomy&#xD;
      diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding&#xD;
      may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload&#xD;
      increases complications and hospital stay after surgery. It is, therefore, important that&#xD;
      optimal fluid levels are achieved.&#xD;
&#xD;
      The aim of the study was to compare intraoperative hemodynamic stability, volume loading and&#xD;
      postoperative complications between group optimised with crystalloids and group optimised&#xD;
      with colloids in patients undergoing neurosurgical procedure. The investigation will include&#xD;
      80 patients, 40 optimised with crystalloids and 40 with colloids.&#xD;
&#xD;
      Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality&#xD;
      will be monitored during and aftre the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>
    <intervention_model_description>one group will get crystalloids and one grou will get colloids for fluid optimisation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consumption of optimisation fluid</measure>
    <time_frame>During surgery</time_frame>
    <description>Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>From the first day until 15 day after the surgery</time_frame>
    <description>The investigators will record the incidence of postoperative complications Complications in different organs will be recorded (nevrological, pulmological, cardiovascular, haematological, infection, wound). The investigator will evaluate the days in the hospital after the surgery and the mortality rate (the number of deaths) for the 15 days after the surgery or until death or the dissmision.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Crystalloids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bolus of crystalloids&#xD;
Bolus of 250 ml crystaloids will be infused regarding the measures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colloids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bolus of colloids&#xD;
Bolus of 250 ml colloids will be infused regarding the measures</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sterofundin (Bolus of crystalloids)</intervention_name>
    <description>Bolus of 250 ml crystaloids infused regarding the measures</description>
    <arm_group_label>Crystalloids</arm_group_label>
    <other_name>Sterofundin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voluven (Bolus of colloids)</intervention_name>
    <description>Bolus of 250 ml colloids infused regarding the measures</description>
    <arm_group_label>Colloids</arm_group_label>
    <other_name>Voluven</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  neurosurgery (tumour, vascular, adenoma), haemodynamic stability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  arrhythmia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Centre Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <zip>1000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Slovenia</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>April 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Jasmina Markovic Bozic</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydroxyethyl Starch Derivatives</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/NCT03249298
org study id: OBKRGKOAIT216
nct id: NCT03249298
lead sponsor: 
Fluid optimization in neurosurgical patients has an important impact on preservation of
      cerebral perfusion pressure and minimization of cerebral oedema during and after the
      craniotomy. The investigators would like to know if crystalloids or colloids are equally
      useful for goal directed therapy in this patients. The investigators will record haemodynamic
      stability, volume loading and postoperative complications and compare two groups of patients.
      One group will be optimised with crystalloids and the second with colloids. The investigators
      will compare also hospital stay and mortality in the two groups.
Hemodynamic stability and maintenance of cerebral perfusion pressure (CPP) are important in
      neurosurgical patients. Fluid management includes maintenance of intravascular volume,
      preservation of cerebral perfusion pressure and minimization of cerebral oedema. Fluid
      management of the neurosurgical patient has advanced from "run them dry" to "run them
      isovolaemic, isotonic and iso-oncotic, but the induction of potential complications by
      current strategies are still unknown. Advanced techniques provide goal directed fluid therapy
      which is currently the gold standard in fluid strategy. In patients undergoing craniotomy
      diuretics, preoperative fasting, induction of general anaesthesia and intraoperative bleeding
      may lead to hypovolemia and poor cerebral perfusion. On the other hand fluid overload
      increases complications and hospital stay after surgery. It is, therefore, important that
      optimal fluid levels are achieved.

      The aim of the study was to compare intraoperative hemodynamic stability, volume loading and
      postoperative complications between group optimised with crystalloids and group optimised
      with colloids in patients undergoing neurosurgical procedure. The investigation will include
      80 patients, 40 optimised with crystalloids and 40 with colloids.

      Hemodynamic stability, volume loading, pooperative complications, hospital stay and mortality
      will be monitored during and aftre the surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one group will get crystalloids and one grou will get colloids for fluid optimisation
primary purpose: Treatment
masking: None (Open Label)
measure: Consumption of optimisation fluid
time frame: During surgery
description: Investigators will record the number of interventions with fluid boluses and volume of optimisation fluid
measure: Postoperative complications
time frame: From the first day until 15 day after the surgery
description: The investigators will record the incidence of postoperative complications Complications in different organs will be recorded (nevrological, pulmological, cardiovascular, haematological, infection, wound). The investigator will evaluate the days in the hospital after the surgery and the mortality rate (the number of deaths) for the 15 days after the surgery or until death or the dissmision.
arm group label: Crystalloids
arm group type: Active Comparator
description: Bolus of crystalloids
Bolus of 250 ml crystaloids will be infused regarding the measures
arm group label: Colloids
arm group type: Active Comparator
description: Bolus of colloids
Bolus of 250 ml colloids will be infused regarding the measures
intervention type: Drug
intervention name: Sterofundin (Bolus of crystalloids)
description: Bolus of 250 ml crystaloids infused regarding the measures
arm group label: Crystalloids
other name: Sterofundin
intervention type: Drug
intervention name: Voluven (Bolus of colloids)
description: Bolus of 250 ml colloids infused regarding the measures
arm group label: Colloids
other name: Voluven
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Slovenia
responsible party type: Principal Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Jasmina Markovic Bozic
investigator title: MD, PhD
mesh term: Postoperative Complications
mesh term: Hydroxyethyl Starch Derivatives
sharing ipd: No