<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/NCT02194101</url>
  </required_header>
  <id_info>
    <org_study_id>GZFPH-IRB-2013-049</org_study_id>
    <nct_id>NCT02194101</nct_id>
  </id_info>
  <brief_title>Supernormal Goal for Proximal Femur Fracture</brief_title>
  <official_title>Supernormal Oxygen Delivery May Not be a Valid Goal for Patients With Proximal Femur Fracture. An Observational Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou First People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou First People's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an observational pilot study of supernormal oxygen delivery goal for patients with&#xD;
      proximal femoral fracture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Augmentation of oxygen delivery using fluids with or without inotropes has been shown to&#xD;
      improve surgical outcome in high-risk patients. Patients with proximal femoral fracture are&#xD;
      considered high risk. However, most of this cohort elderly patients have poor cardiovascular&#xD;
      condition and may not achieve the oxygen delivery goal. We will perform an observational&#xD;
      pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients&#xD;
      with proximal femoral fracture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxgen delivery index</measure>
    <time_frame>At the end of 4 hour goal-directed therapy</time_frame>
    <description>To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hear rate augmentation</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemodynamic response</measure>
    <time_frame>Day 1</time_frame>
    <description>Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fluid volume administrated</measure>
    <time_frame>intraoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Day 30</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>day 5</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Femoral Fractures</condition>
  <arm_group>
    <arm_group_label>Supernormal oxygen delivery goal therapy</arm_group_label>
    <description>Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Supernormal oxygen delivery goal therapy</intervention_name>
    <description>A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.</description>
    <arm_group_label>Supernormal oxygen delivery goal therapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur&#xD;
        fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged over 70 yr&#xD;
&#xD;
          -  Weight over 35 kg&#xD;
&#xD;
          -  Underwent proximal femur fracture (PFF) surgery under peripheral nerve block and&#xD;
             laryngeal mask airway anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who could be harmed due to the treatment (ongoing myocardial infarction,&#xD;
             chronic dialysis)&#xD;
&#xD;
          -  Monoamine oxidase inhibitor use within the last 14 days&#xD;
&#xD;
          -  Pathological fractures and conditions&#xD;
&#xD;
          -  Inability to give informed consent(as judged by a research team member)&#xD;
&#xD;
          -  Anticipated difficulties obtaining data during the first postoperative year (as judged&#xD;
             by a research team member)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiangcai Ruan, MD., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiangcai Ruan, MD, PhD</last_name>
    <phone>+8620-81048306</phone>
    <email>xc_ruan@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jingwen Guo</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou First Municipal People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Pestana D, Espinosa E, Eden A, Najera D, Collar L, Aldecoa C, Higuera E, Escribano S, Bystritski D, Pascual J, Fernandez-Garijo P, de Prada B, Muriel A, Pizov R. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitoring in major abdominal surgery: a prospective, randomized, multicenter, pragmatic trial: POEMAS Study (PeriOperative goal-directed thErapy in Major Abdominal Surgery). Anesth Analg. 2014 Sep;119(3):579-587. doi: 10.1213/ANE.0000000000000295.</citation>
    <PMID>25010820</PMID>
  </results_reference>
  <results_reference>
    <citation>Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. No abstract available.</citation>
    <PMID>24841970</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <results_reference>
    <citation>Bartha E, Arfwedson C, Imnell A, Fernlund ME, Andersson LE, Kalman S. Randomized controlled trial of goal-directed haemodynamic treatment in patients with proximal femoral fracture. Br J Anaesth. 2013 Apr;110(4):545-53. doi: 10.1093/bja/aes468. Epub 2012 Dec 28.</citation>
    <PMID>23274782</PMID>
  </results_reference>
  <results_reference>
    <citation>Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.</citation>
    <PMID>21624138</PMID>
  </results_reference>
  <results_reference>
    <citation>Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.</citation>
    <PMID>21048092</PMID>
  </results_reference>
  <results_reference>
    <citation>Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane Systematic Review. Br J Anaesth. 2013 Oct;111(4):535-48. doi: 10.1093/bja/aet155. Epub 2013 May 9.</citation>
    <PMID>23661403</PMID>
  </results_reference>
  <results_reference>
    <citation>Bisgaard J, Gilsaa T, Ronholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17.</citation>
    <PMID>22897633</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>July 16, 2014</last_update_submitted>
  <last_update_submitted_qc>July 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou First People's Hospital</investigator_affiliation>
    <investigator_full_name>Xiangcai Ruan</investigator_full_name>
    <investigator_title>Vice-Chair</investigator_title>
  </responsible_party>
  <keyword>oxygen delivery</keyword>
  <keyword>proximal femoral fracture</keyword>
  <keyword>goal-directed therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</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/NCT02194101
org study id: GZFPH-IRB-2013-049
nct id: NCT02194101
lead sponsor: 
has dmc: No
This is an observational pilot study of supernormal oxygen delivery goal for patients with
      proximal femoral fracture.
Augmentation of oxygen delivery using fluids with or without inotropes has been shown to
      improve surgical outcome in high-risk patients. Patients with proximal femoral fracture are
      considered high risk. However, most of this cohort elderly patients have poor cardiovascular
      condition and may not achieve the oxygen delivery goal. We will perform an observational
      pilot study whether the supernormal oxygen delivery is a valid hemodynamic goal for patients
      with proximal femoral fracture.
observational model: Cohort
time perspective: Prospective
measure: Oxgen delivery index
time frame: At the end of 4 hour goal-directed therapy
description: To attain a improved oxygen delivery index at the end of 4 hour goal-directed therapy
measure: Hear rate augmentation
time frame: Day 1
measure: Hemodynamic response
time frame: Day 1
description: Including stroke volume, cardiac index, base excess, lactate, hemoglobin, and urine output.
measure: fluid volume administrated
time frame: intraoperatively
measure: Length of hospital stay
time frame: Day 30
measure: Postoperative morbidity
time frame: day 5
arm group label: Supernormal oxygen delivery goal therapy
description: Patients will be aged over 70 yr and weight over 35 kg, and undergoing proximal femur fracture (PFF) surgery under peripheral nerve block and laryngeal mask airway anesthesia.
intervention type: Procedure
intervention name: Supernormal oxygen delivery goal therapy
description: A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.
arm group label: Supernormal oxygen delivery goal therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Xiangcai Ruan, MD., PhD.
role: Principal Investigator
affiliation: Guangzhou First Municipal People's Hospital,Guangzhou,Guangdong,China,510180
last name: Xiangcai Ruan, MD, PhD
phone: +8620-81048306
email: xc_ruan@hotmail.com
last name: Jingwen Guo
facility: 
country: China
citation: Pestana D, Espinosa E, Eden A, Najera D, Collar L, Aldecoa C, Higuera E, Escribano S, Bystritski D, Pascual J, Fernandez-Garijo P, de Prada B, Muriel A, Pizov R. Perioperative goal-directed hemodynamic optimization using noninvasive cardiac output monitoring in major abdominal surgery: a prospective, randomized, multicenter, pragmatic trial: POEMAS Study (PeriOperative goal-directed thErapy in Major Abdominal Surgery). Anesth Analg. 2014 Sep;119(3):579-587. doi: 10.1213/ANE.0000000000000295.
PMID: 25010820
citation: Bennett-Guerrero E. Hemodynamic goal-directed therapy in high-risk surgical patients. JAMA. 2014 Jun 4;311(21):2177-8. doi: 10.1001/jama.2014.5306. No abstract available.
PMID: 24841970
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: Bartha E, Arfwedson C, Imnell A, Fernlund ME, Andersson LE, Kalman S. Randomized controlled trial of goal-directed haemodynamic treatment in patients with proximal femoral fracture. Br J Anaesth. 2013 Apr;110(4):545-53. doi: 10.1093/bja/aes468. Epub 2012 Dec 28.
PMID: 23274782
citation: Cecconi M, Fasano N, Langiano N, Divella M, Costa MG, Rhodes A, Della Rocca G. Goal-directed haemodynamic therapy during elective total hip arthroplasty under regional anaesthesia. Crit Care. 2011;15(3):R132. doi: 10.1186/cc10246. Epub 2011 May 30.
PMID: 21624138
citation: Davies SJ, Yates D, Wilson RJ. Dopexamine has no additional benefit in high-risk patients receiving goal-directed fluid therapy undergoing major abdominal surgery. Anesth Analg. 2011 Jan;112(1):130-8. doi: 10.1213/ANE.0b013e3181fcea71. Epub 2010 Nov 3.
PMID: 21048092
citation: Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes after surgery: a Cochrane Systematic Review. Br J Anaesth. 2013 Oct;111(4):535-48. doi: 10.1093/bja/aet155. Epub 2013 May 9.
PMID: 23661403
citation: Bisgaard J, Gilsaa T, Ronholm E, Toft P. Optimising stroke volume and oxygen delivery in abdominal aortic surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2013 Feb;57(2):178-88. doi: 10.1111/j.1399-6576.2012.02756.x. Epub 2012 Aug 17.
PMID: 22897633
responsible party type: Principal Investigator
investigator affiliation: Guangzhou First People's Hospital
investigator full name: Xiangcai Ruan
investigator title: Vice-Chair
mesh term: Fractures, Bone
mesh term: Femoral Fractures