<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/NCT01729364</url>
  </required_header>
  <id_info>
    <org_study_id>vätskestudien</org_study_id>
    <nct_id>NCT01729364</nct_id>
  </id_info>
  <brief_title>Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function</brief_title>
  <official_title>Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sahlgrenska University Hospital, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients&#xD;
      postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen&#xD;
      demand.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery.&#xD;
      Substantial controversy persists regarding the best choice of fluid to be used for&#xD;
      resuscitation in this setting regarding renal function and oxygen supply-demand matching. In&#xD;
      our study we aim to investigate differences in functional renal parameters by dividing&#xD;
      patients postoperatively in two groups, substituted either with crystalloid fluid,&#xD;
      Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and&#xD;
      renal hemodynamics will be measured before (baseline) and after fluid administration by blood&#xD;
      sampling and thermodilution in both pulmonary artery catheter and renal vein catheter.&#xD;
      Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and&#xD;
      renal oxygen extraction rate which we aim to compare between groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints</measure>
    <time_frame>125min after baseline-measures</time_frame>
    <description>GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>crystalloid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>colloid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>crystalloid</intervention_name>
    <arm_group_label>crystalloid</arm_group_label>
    <other_name>Ringer Lactate</other_name>
    <other_name>NaCl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>colloid</intervention_name>
    <arm_group_label>colloid</arm_group_label>
    <other_name>Voluven</other_name>
    <other_name>Venofundin</other_name>
    <other_name>Tetraspan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective fast track CABG patients, postoperative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hemodynamic instability&#xD;
&#xD;
          -  preoperative renal impairment&#xD;
&#xD;
          -  major postoperative bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jenny Skytte Larsson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sven-Erik Ricksten, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Sahlgrenska University Hospital, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital/Thoracic Intensive Care</name>
      <address>
        <city>Göteborg</city>
        <state>Västra Götaland</state>
        <zip>41345</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 20, 2015</last_update_submitted>
  <last_update_submitted_qc>May 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Jenny Skytte Larsson</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>elective CABG</keyword>
  <keyword>renal impairment</keyword>
  <keyword>GFR</keyword>
  <keyword>renal blood flow</keyword>
  <keyword>colloid</keyword>
  <keyword>crystalloid</keyword>
  <keyword>thermodilution technique</keyword>
  <keyword>oxygen supply demand</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729364
org study id: vätskestudien
nct id: NCT01729364
lead sponsor: 
has dmc: No
Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients
      postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen
      demand.
Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery.
      Substantial controversy persists regarding the best choice of fluid to be used for
      resuscitation in this setting regarding renal function and oxygen supply-demand matching. In
      our study we aim to investigate differences in functional renal parameters by dividing
      patients postoperatively in two groups, substituted either with crystalloid fluid,
      Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and
      renal hemodynamics will be measured before (baseline) and after fluid administration by blood
      sampling and thermodilution in both pulmonary artery catheter and renal vein catheter.
      Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and
      renal oxygen extraction rate which we aim to compare between groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints
time frame: 125min after baseline-measures
description: GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)
arm group label: crystalloid
arm group type: Experimental
description: crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes
arm group label: colloid
arm group type: Experimental
description: colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes
intervention type: Drug
intervention name: crystalloid
arm group label: crystalloid
other name: Ringer Lactate
other name: NaCl
intervention type: Drug
intervention name: colloid
arm group label: colloid
other name: Voluven
other name: Venofundin
other name: Tetraspan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jenny Skytte Larsson, MD
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Sweden
last name: Sven-Erik Ricksten, Professor
role: Study Chair
affiliation: Sahlgrenska University Hospital, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Jenny Skytte Larsson
investigator title: MD
mesh term: Renal Insufficiency