<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/NCT03288051</url>
  </required_header>
  <id_info>
    <org_study_id>Free Flap Microcirculation</org_study_id>
    <nct_id>NCT03288051</nct_id>
  </id_info>
  <brief_title>Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Free Flaps</brief_title>
  <official_title>Effects of Intraoperative, Goal-directed Crystalloid vs. Colloid Fluid Resuscitation on Microcirculation in Free Flap Reconstruction of Intraoral Tumours.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Oral and Maxillofacial Surgery, University of Szeged</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Surgical Research, University of Szeged</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Szeged University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maintaining satisfactory tissue perfusion is an essential of success during reconstructive&#xD;
      free flap surgery following malign oral cavity tumours. Intra- and postoperative&#xD;
      goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output&#xD;
      monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary)&#xD;
      might be superior to conventional, central venous and arterial pressure monitoring in terms&#xD;
      of morbidity, complications, optimal fluid balance and days spent in hospital. However, there&#xD;
      is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on&#xD;
      microcirculation of free flaps implanted in the oral cavity during the post-operative period.&#xD;
      The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring&#xD;
      based, goal-directed fluid therapy on microcirculation of forearm flaps during the&#xD;
      perioperative period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 28, 2014</start_date>
  <completion_date type="Actual">September 19, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Pulse pressure variation during the operation and the post-operative 24 hours</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assesment of free falp microcirculation by laser dopler flowmetry method.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes of Cardiac Index during the operation and the post-operative 24 hours.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean arterial pressure during the operation and the post-operative 24 hours.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of Intensive Care Unit stay</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of surgical or non-surgical complications.</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital stay</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Optimal Tissue Perfusion</condition>
  <arm_group>
    <arm_group_label>Crystalloid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Colloid group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluid management</intervention_name>
    <description>Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.</description>
    <arm_group_label>Colloid group</arm_group_label>
    <arm_group_label>Crystalloid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <description>Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.</description>
    <arm_group_label>Colloid group</arm_group_label>
    <arm_group_label>Crystalloid group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dobutamine</intervention_name>
    <description>Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.</description>
    <arm_group_label>Colloid group</arm_group_label>
    <arm_group_label>Crystalloid group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age over 18&#xD;
&#xD;
          -  Tumour location: intraoral&#xD;
&#xD;
          -  Free flap type: radial forearm&#xD;
&#xD;
          -  Signed informed concent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Vulnerable subject as defined in International Standards Organization 14155:2011&#xD;
&#xD;
          -  End stage oral cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Anaesthesiology and Intensive Therapy</name>
      <address>
        <city>Szeged</city>
        <state>Csongrád</state>
        <zip>6725</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <citation>Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.</citation>
    <PMID>24010849</PMID>
  </reference>
  <reference>
    <citation>Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.</citation>
    <PMID>19944567</PMID>
  </reference>
  <reference>
    <citation>Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. Erratum In: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added.</citation>
    <PMID>26162676</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Szeged University</investigator_affiliation>
    <investigator_full_name>Zsolt Molnár, MD, PhD, DEAA</investigator_full_name>
    <investigator_title>head of department</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dobutamine</mesh_term>
    <mesh_term>Norepinephrine</mesh_term>
  </intervention_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/NCT03288051
org study id: Free Flap Microcirculation
nct id: NCT03288051
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Maintaining satisfactory tissue perfusion is an essential of success during reconstructive
      free flap surgery following malign oral cavity tumours. Intra- and postoperative
      goal-directed fluid therapy is an appropriate tool for that. Continuous cardiac output
      monitoring based fluid loading (complemented with vasopressor and/or inotropes if necessary)
      might be superior to conventional, central venous and arterial pressure monitoring in terms
      of morbidity, complications, optimal fluid balance and days spent in hospital. However, there
      is no data describing the effects of goal-directed fluid therapy (crystalloid or colloid) on
      microcirculation of free flaps implanted in the oral cavity during the post-operative period.
      The aim of this study is to observe the effects of continuous macrohaemodynamic monitoring
      based, goal-directed fluid therapy on microcirculation of forearm flaps during the
      perioperative period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Changes of Pulse pressure variation during the operation and the post-operative 24 hours
time frame: 24 hours
measure: Assesment of free falp microcirculation by laser dopler flowmetry method.
time frame: 24 hours
measure: Total need of Norepinephrine and Dobutamine during surgery and the post-operative 24 hours.
time frame: 24 hours
measure: Changes of Cardiac Index during the operation and the post-operative 24 hours.
time frame: 24 hours
measure: Mean arterial pressure during the operation and the post-operative 24 hours.
time frame: 24 hours
measure: Length of Intensive Care Unit stay
time frame: 24 hours
measure: Number of surgical or non-surgical complications.
time frame: 24 hours
measure: Length of Hospital stay
time frame: 10 days
arm group label: Crystalloid group
arm group type: Active Comparator
arm group label: Colloid group
arm group type: Active Comparator
intervention type: Other
intervention name: Fluid management
description: Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
arm group label: Colloid group
arm group label: Crystalloid group
intervention type: Drug
intervention name: Norepinephrine
description: Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.
arm group label: Colloid group
arm group label: Crystalloid group
intervention type: Drug
intervention name: Dobutamine
description: Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.
arm group label: Colloid group
arm group label: Crystalloid group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hungary
citation: Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
PMID: 24010849
citation: Holzle F, Rau A, Loeffelbein DJ, Mucke T, Kesting MR, Wolff KD. Results of monitoring fasciocutaneous, myocutaneous, osteocutaneous and perforator flaps: 4-year experience with 166 cases. Int J Oral Maxillofac Surg. 2010 Jan;39(1):21-8. doi: 10.1016/j.ijom.2009.10.012. Epub 2009 Nov 26.
PMID: 19944567
citation: Cecconi M, Hofer C, Teboul JL, Pettila V, Wilkman E, Molnar Z, Della Rocca G, Aldecoa C, Artigas A, Jog S, Sander M, Spies C, Lefrant JY, De Backer D; FENICE Investigators; ESICM Trial Group. Fluid challenges in intensive care: the FENICE study: A global inception cohort study. Intensive Care Med. 2015 Sep;41(9):1529-37. doi: 10.1007/s00134-015-3850-x. Epub 2015 Jul 11. Erratum In: Intensive Care Med. 2015 Sep;41(9):1737-8. multiple investigator names added.
PMID: 26162676
responsible party type: Principal Investigator
investigator affiliation: Szeged University
investigator full name: Zsolt Molnár, MD, PhD, DEAA
investigator title: head of department
mesh term: Dobutamine
mesh term: Norepinephrine