<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/NCT01689506</url>
  </required_header>
  <id_info>
    <org_study_id>VOLU-011-C P4</org_study_id>
    <secondary_id>2011-005734-18</secondary_id>
    <nct_id>NCT01689506</nct_id>
  </id_info>
  <brief_title>Fluid Resuscitation in Patients Suffering From Burns Injury</brief_title>
  <official_title>Prospective Randomised Controlled Open-label Explorative Multi-centre Pilot Trial of Volulyte®-Supplemented Versus Albumin-supplemented Fluid Resuscitation for Major Burns</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fresenius Kabi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fresenius Kabi</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical study compares two fluid resuscitation treatments in patients suffering from&#xD;
      burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be&#xD;
      administered as infusion solutions. It will be evaluated whether Volulyte® is effective and&#xD;
      safe, and provides any benefit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe burns injury presents a unique resuscitation problem due to simultaneous loss of&#xD;
      electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and&#xD;
      protein from the circulation into the interstitial compartment. In the post shock phase of&#xD;
      burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a&#xD;
      positive fluid balance of many litres. This pilot study will compare two burns fluid&#xD;
      resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte&#xD;
      solution, Volulyte 6%, versus supplementation with Human Serum Albumin, HSA 50g/L) on patient&#xD;
      outcome with particular regard to fluid balance at 24 hours after burns injury (primary&#xD;
      variable).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study stopped due to low recruitment&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative fluid balance (input-output)</measure>
    <time_frame>at 24 hours after burns injury</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative fluid balance (input-output)</measure>
    <time_frame>at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oedema monitoring: patient's weight, circumference measurement of unburned limb</measure>
    <time_frame>once daily until day 7 after burns injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urine output</measure>
    <time_frame>hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemodynamics</measure>
    <time_frame>hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder pressure</measure>
    <time_frame>once daily until day 7 after burns injury</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of vasoactive and inotropic drugs</measure>
    <time_frame>until 24 hours after randomisation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Burns</condition>
  <arm_group>
    <arm_group_label>Volulyte</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Human Serum Albumin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Volulyte</intervention_name>
    <description>6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution will be intravenously infused in order to achieve and maintain predefined hemodynamics goals and may be given up to a total daily dose of 50 mL/kg body weight/day.</description>
    <arm_group_label>Volulyte</arm_group_label>
    <other_name>6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human Serum Albumin</intervention_name>
    <description>5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.</description>
    <arm_group_label>Human Serum Albumin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patients ≥18 years of age&#xD;
&#xD;
          -  15%≥ Burn Total Body Surface Area Injury ≤60%&#xD;
&#xD;
          -  Signed written informed consent from patient or legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt;80 years&#xD;
&#xD;
          -  Delay of patient randomisation &gt;8 hours post-burn&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Known renal failure with oliguria or anuria not related to hypovolaemia (e.g. patients&#xD;
             receiving dialysis treatment)&#xD;
&#xD;
          -  High voltage electrical conduction injury&#xD;
&#xD;
          -  Known severe liver disease&#xD;
&#xD;
          -  Known fluid overload (hyperhydration), especially in cases of pulmonary oedema and&#xD;
             congestive cardiac failure&#xD;
&#xD;
          -  Intracranial bleeding (known active or suspicion of intracranial bleeding)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naiem Moiemen, PhD MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2WB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>June 25, 2014</last_update_submitted>
  <last_update_submitted_qc>June 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burns</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/NCT01689506
org study id: VOLU-011-C P4
secondary id: 2011-005734-18
nct id: NCT01689506
lead sponsor: 
has dmc: Yes
This clinical study compares two fluid resuscitation treatments in patients suffering from
      burns injury. The treatments are Volulyte® and Human Serum Albumin (HSA) which will be
      administered as infusion solutions. It will be evaluated whether Volulyte® is effective and
      safe, and provides any benefit.
Severe burns injury presents a unique resuscitation problem due to simultaneous loss of
      electrolyte and protein-rich exudate from the burn wound itself and leakage of fluid and
      protein from the circulation into the interstitial compartment. In the post shock phase of
      burn resuscitation, patients frequently suffer oedema of unburned tissues and organs and a
      positive fluid balance of many litres. This pilot study will compare two burns fluid
      resuscitation regimes (supplementation with 6% HES 130/0.4 in an isotonic electrolyte
      solution, Volulyte 6%, versus supplementation with Human Serum Albumin, HSA 50g/L) on patient
      outcome with particular regard to fluid balance at 24 hours after burns injury (primary
      variable).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Cumulative fluid balance (input-output)
time frame: at 24 hours after burns injury
measure: Cumulative fluid balance (input-output)
time frame: at 8 hours after burns injury, at 24 hours after randomisation, and until day 7 after burns injury
measure: Oedema monitoring: patient's weight, circumference measurement of unburned limb
time frame: once daily until day 7 after burns injury
measure: Urine output
time frame: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, once daily until day 7 after burns injury
measure: Haemodynamics
time frame: hourly until 24 hours after burns injury, at 24 hours after randomization and, thereafter, 4 times daily until day 7 after burns injury
measure: Bladder pressure
time frame: once daily until day 7 after burns injury
measure: Use of vasoactive and inotropic drugs
time frame: until 24 hours after randomisation
arm group label: Volulyte
arm group type: Experimental
description: Volulyte 6%-supplemented arm: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (solution for infusion)
arm group label: Human Serum Albumin
arm group type: Active Comparator
description: 5% Albumin-supplemented arm: Human Serum Albumin (HSA 50g/L, solution for infusion)
intervention type: Drug
intervention name: Volulyte
description: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution will be intravenously infused in order to achieve and maintain predefined hemodynamics goals and may be given up to a total daily dose of 50 mL/kg body weight/day.
arm group label: Volulyte
other name: 6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution
intervention type: Drug
intervention name: Human Serum Albumin
description: 5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.
arm group label: Human Serum Albumin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Naiem Moiemen, PhD MD
role: Principal Investigator
affiliation: Plastic and Burns Department, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Queen Elizabeth Medical Centre
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Burns