<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/NCT03278548</url>
  </required_header>
  <id_info>
    <org_study_id>HC-G-H-1504</org_study_id>
    <secondary_id>HE06-024-CP4</secondary_id>
    <nct_id>NCT03278548</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery</brief_title>
  <acronym>PHOENICS</acronym>
  <official_title>Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Society of Anaesthesiology and Intensive Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fresenius Kabi</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution&#xD;
      (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective&#xD;
      abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">July 6, 2022</completion_date>
  <primary_completion_date type="Actual">April 9, 2022</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups</measure>
    <time_frame>post-operative days 1-3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal function</measure>
    <time_frame>until 1 year after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calculated red blood cell (RBC) loss</measure>
    <time_frame>on post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated intra-operative blood loss</measure>
    <time_frame>end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coagulation</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>until post-operative day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major post-operative complications</measure>
    <time_frame>until post-operative day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite of mortality and major post-operative complications (including renal)</measure>
    <time_frame>until post-operative day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of administered investigational product</measure>
    <time_frame>until 24 hours after investigational product treatment start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss]</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body temperature</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean arterial pressure</measure>
    <time_frame>until post-operative day 3, if available</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic arterial blood pressure</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic arterial blood pressure</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central venous pressure (if available)</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration]</measure>
    <time_frame>until 24 hours after investigational product treatment start</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of carbon dioxide</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of oxygen</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bicarbonate</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial oxygen saturation</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haematocrit</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pH</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Base Excess</measure>
    <time_frame>until end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lactate</measure>
    <time_frame>until post-operative day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central venous oxygen saturation (if available)</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum sodium</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum potassium</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum calcium</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum chloride</measure>
    <time_frame>until post-operative day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the hospital/intensive care unit</measure>
    <time_frame>until post-operative day 90</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hours on mechanical ventilation</measure>
    <time_frame>until post-operative day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2290</enrollment>
  <condition>Hypovolaemia Due to Acute Blood Loss</condition>
  <arm_group>
    <arm_group_label>Volulyte 6%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volulyte 6% solution for infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ionolyte</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ionolyte solution for infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Volulyte 6%</intervention_name>
    <description>Solution for infusion</description>
    <arm_group_label>Volulyte 6%</arm_group_label>
    <other_name>Hydroxyethyl starch 130/0.4</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ionolyte</intervention_name>
    <description>Solution for infusion</description>
    <arm_group_label>Ionolyte</arm_group_label>
    <other_name>Electrolyte solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Male or female adult patients &gt; 40 and ≤ 85 years of age. Women of child bearing&#xD;
             potential must test negative on standard pregnancy test (urine or serum)&#xD;
&#xD;
          -  Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml&#xD;
&#xD;
          -  ASA Physical Status II - III&#xD;
&#xD;
          -  Signed written informed consent form&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Hypersensitivity to the active substances or to any of the other excipients of the&#xD;
             investigational medicinal products&#xD;
&#xD;
          -  Body weight ≥ 140 kg&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Burns&#xD;
&#xD;
          -  Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic renal replacement&#xD;
             therapy&#xD;
&#xD;
          -  Intracranial or cerebral haemorrhage&#xD;
&#xD;
          -  Critically ill patients (typically admitted to the intensive care unit)&#xD;
&#xD;
          -  Hyperhydration&#xD;
&#xD;
          -  Pulmonary oedema&#xD;
&#xD;
          -  Dehydration&#xD;
&#xD;
          -  Hyperkalaemia&#xD;
&#xD;
          -  Severe hypernatraemia&#xD;
&#xD;
          -  Severe hyperchloraemia&#xD;
&#xD;
          -  Severely impaired hepatic function&#xD;
&#xD;
          -  Congestive heart failure&#xD;
&#xD;
          -  Severe coagulopathy&#xD;
&#xD;
          -  Organ transplant patients&#xD;
&#xD;
          -  Metabolic alkalosis&#xD;
&#xD;
          -  Simultaneous participation in another interventional clinical trial (drugs or medical&#xD;
             devices studies)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wolfgang F. Buhre, Prof. Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital of Barmherzige Brüder</name>
      <address>
        <city>Sankt Veit</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Social Medical Center East - Donauspital</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint Luc</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Maria Middelares</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Sveti Duh</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Sisters of Mercy</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zagreb</name>
      <address>
        <city>Zagreb</city>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolín Hospital</name>
      <address>
        <city>Kolín</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Military Hospital Prague</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General University Hospital in Prague</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Prague</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Centre Pierre Oudot</name>
      <address>
        <city>Bourgoin-Jallieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Centre Montauban</name>
      <address>
        <city>Montauban</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HP Paris (Salpêtrière)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Saint-Antoine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Foch Suresnes</name>
      <address>
        <city>Suresnes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Jean Bernard</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carl-Thiem-Klinikum</name>
      <address>
        <city>Cottbus</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios Amper-Klinikum</name>
      <address>
        <city>Dachau</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Schleswig-Holstein Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken der Stadt Köln</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Marburg</name>
      <address>
        <city>Marburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Munich</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Münster</name>
      <address>
        <city>Münster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg AÖR</name>
      <address>
        <city>Oldenburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regio Klinikum Pinneberg GmbH</name>
      <address>
        <city>Pinneberg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam Medical Centre</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Martini General Hospital Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center (UMC) Maastricht</name>
      <address>
        <city>Maastricht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center Gdansk</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Silesia</name>
      <address>
        <city>Katowice</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Zespolony</name>
      <address>
        <city>Konin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny im. Św. Łukasza</name>
      <address>
        <city>Końskie</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jagiollonian University Hospital Medical College</name>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of Lublin</name>
      <address>
        <city>Lublin</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karol Marcinkowski Medical University in Poznań</name>
      <address>
        <city>Poznań</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital in Wroclaw</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Wiśniowa</name>
      <address>
        <city>Zielona Góra</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundeni Clinical Institute 1</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundeni Clinical Institute 2</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Elias Bucharest</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency county hospital Cluj</name>
      <address>
        <city>Cluj-Napoca</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barcelona Clinic Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital General Del Elche</name>
      <address>
        <city>Elche</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria Dr. Negrín</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Alcorcon</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quironsalud</name>
      <address>
        <city>Málaga</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic la Fe</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Rio Hortega</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Croatia</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HES</keyword>
  <keyword>HES 130</keyword>
  <keyword>Hydroxyethyl starch</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypovolemia</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/NCT03278548
org study id: HC-G-H-1504
secondary id: HE06-024-CP4
nct id: NCT03278548
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution
      (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective
      abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Difference in mean estimated glomerular filtration rate (eGFR) (calculated from highest cystatin-C levels measured during post-operative days 1-3 (POD 1-3)) between the two treatment groups
time frame: post-operative days 1-3
measure: Renal function
time frame: until 1 year after surgery
measure: Calculated red blood cell (RBC) loss
time frame: on post-operative day 3
measure: Estimated intra-operative blood loss
time frame: end of surgery
measure: Coagulation
time frame: until post-operative day 1
measure: Inflammation
time frame: until post-operative day 1
measure: Adverse events
time frame: until post-operative day 90
measure: Major post-operative complications
time frame: until post-operative day 90
measure: Mortality
time frame: 1 year
measure: Composite of mortality and major post-operative complications (including renal)
time frame: until post-operative day 90
measure: Total volume of administered investigational product
time frame: until 24 hours after investigational product treatment start
measure: Fluid balance [Sum of volume of all intravenous medication (including investigational product and blood products) minus sum of volume of urine output (if available), drainage and estimated intra-operative blood loss]
time frame: until post-operative day 3
measure: Heart Rate
time frame: until post-operative day 3
measure: Body temperature
time frame: until post-operative day 3
measure: Mean arterial pressure
time frame: until post-operative day 3, if available
measure: Systolic arterial blood pressure
time frame: until end of surgery
measure: Diastolic arterial blood pressure
time frame: until end of surgery
measure: Central venous pressure (if available)
time frame: until end of surgery
measure: Haemodynamics readings as required to determine volume responsiveness [at least one parameter (stroke volume, stroke volume variation, stroke volume index, pulse pressure variation, mean arterial pressure) has to be used to guide volume administration]
time frame: until 24 hours after investigational product treatment start
measure: Partial pressure of carbon dioxide
time frame: until end of surgery
measure: Partial pressure of oxygen
time frame: until end of surgery
measure: Bicarbonate
time frame: until end of surgery
measure: Arterial oxygen saturation
time frame: until end of surgery
measure: Haemoglobin
time frame: until post-operative day 3
measure: Haematocrit
time frame: until post-operative day 3
measure: pH
time frame: until end of surgery
measure: Base Excess
time frame: until end of surgery
measure: Lactate
time frame: until post-operative day 3
measure: Central venous oxygen saturation (if available)
time frame: until post-operative day 1
measure: Serum sodium
time frame: until post-operative day 1
measure: Serum potassium
time frame: until post-operative day 1
measure: Serum calcium
time frame: until post-operative day 1
measure: Serum chloride
time frame: until post-operative day 1
measure: Length of stay in the hospital/intensive care unit
time frame: until post-operative day 90
measure: Hours on mechanical ventilation
time frame: until post-operative day 7
arm group label: Volulyte 6%
arm group type: Experimental
description: Volulyte 6% solution for infusion
arm group label: Ionolyte
arm group type: Active Comparator
description: Ionolyte solution for infusion
intervention type: Drug
intervention name: Volulyte 6%
description: Solution for infusion
arm group label: Volulyte 6%
other name: Hydroxyethyl starch 130/0.4
intervention type: Drug
intervention name: Ionolyte
description: Solution for infusion
arm group label: Ionolyte
other name: Electrolyte solution
criteria: 
gender: All
minimum age: 41 Years
maximum age: 85 Years
healthy volunteers: No
last name: Wolfgang F. Buhre, Prof. Dr. med.
role: Study Chair
affiliation: Department of Anesthesiology and Pain Management, Maastricht University, The Netherlands
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country: Austria
country: Belgium
country: Croatia
country: Czechia
country: France
country: Germany
country: Netherlands
country: Poland
country: Romania
country: Spain
responsible party type: Sponsor
mesh term: Hypovolemia