<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/NCT01735435</url>
  </required_header>
  <id_info>
    <org_study_id>5744</org_study_id>
    <nct_id>NCT01735435</nct_id>
  </id_info>
  <brief_title>Tight Caloric Balance in Geriatric Patients</brief_title>
  <acronym>TICACOSiGP</acronym>
  <official_title>Tight Caloric Balance in Geriatric Patients After Hip Fracture.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study to assess the impact of nutritional support guided by repeated&#xD;
      measurements of REE in geriatric patients following surgery for hip fractures.&#xD;
&#xD;
      Our hypothesis is that tight caloric control will reduce the risk of significant&#xD;
      postoperative complications in geriatric patients following surgery for hip fractures.&#xD;
&#xD;
      Study Design :Prospective, Single center, Randomized, Unblinded study. Study&#xD;
      Population:geriatric patients following surgery for hip fractures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome:&#xD;
&#xD;
      presence of postoperative complications,hospital length of stay.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      energy intake and calculated energy balance&#xD;
&#xD;
      Study Procedure:&#xD;
&#xD;
      eligible patients will be randomly assigned to 2 groups: the tight calorie&#xD;
      (intervention)group and the control group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of postoperative complications</measure>
    <time_frame>up to day 14</time_frame>
    <description>incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Energy balance</measure>
    <time_frame>prior to surgery and up to 14 day</time_frame>
    <description>energy intake and calculated energy balance.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Nutrition Assessment</condition>
  <arm_group>
    <arm_group_label>Group 2 (Control group)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1 (Indirect Calorimetry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Indirect Calorimetry</intervention_name>
    <description>The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.&#xD;
IC measurements:after a fasting period of at least 6 hours at three time periods : on admission to the study,between 24-48 hours following surgery and on the 7th day of the study.Measurements were performed by an experienced nurse or dietician,the device was automatically calibrated before each measurement and the REE was recorded after 15 minutes.</description>
    <arm_group_label>Group 1 (Indirect Calorimetry)</arm_group_label>
    <other_name>Energy intake according to REE measurements(nutrition according to the individual energy requirements)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patients older than 65 years who were admitted to the unit following hip fracture within 48&#xD;
        hours of the injury and in whom orthopedic surgery was considered the treatment of choice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients were excluded if they presented to hospital &gt; 48 hours after the injury, were&#xD;
        receiving steroids and/or immunosuppression therapy; in the presence of active oncologic&#xD;
        disease, multiple fractures, diagnosed dementia or in the event that patients required&#xD;
        supplemental nasal oxygen which precludes the measurement of resting energy expenditure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre Singer, Professor,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RabinMC,Beilinson Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>RabinMC</name>
      <address>
        <city>Petah Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>November 27, 2012</last_update_submitted>
  <last_update_submitted_qc>November 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Pierre singer</investigator_full_name>
    <investigator_title>Professor Pierre Singer, MD</investigator_title>
  </responsible_party>
  <keyword>geriatric patients</keyword>
  <keyword>nutritional support</keyword>
  <!-- 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/NCT01735435
org study id: 5744
nct id: NCT01735435
lead sponsor: 
has dmc: Yes
The aim of this study to assess the impact of nutritional support guided by repeated
      measurements of REE in geriatric patients following surgery for hip fractures.

      Our hypothesis is that tight caloric control will reduce the risk of significant
      postoperative complications in geriatric patients following surgery for hip fractures.

      Study Design :Prospective, Single center, Randomized, Unblinded study. Study
      Population:geriatric patients following surgery for hip fractures.
The primary outcome:

      presence of postoperative complications,hospital length of stay.

      Secondary outcomes:

      energy intake and calculated energy balance

      Study Procedure:

      eligible patients will be randomly assigned to 2 groups: the tight calorie
      (intervention)group and the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Rate of postoperative complications
time frame: up to day 14
description: incidence of postoperative complications following admission up to day 14/or hospital discharge and length of hospital stay will be evaluated
measure: Energy balance
time frame: prior to surgery and up to 14 day
description: energy intake and calculated energy balance.
arm group label: Group 2 (Control group)
arm group type: No Intervention
description: Group 2(Control group)-patients in this group received nutrition according to the standard hospital dietary regimen.
arm group label: Group 1 (Indirect Calorimetry)
arm group type: Experimental
description: Group 1(Indirect Calorimetry)-The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.
intervention type: Other
intervention name: Indirect Calorimetry
description: The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.
IC measurements:after a fasting period of at least 6 hours at three time periods : on admission to the study,between 24-48 hours following surgery and on the 7th day of the study.Measurements were performed by an experienced nurse or dietician,the device was automatically calibrated before each measurement and the REE was recorded after 15 minutes.
arm group label: Group 1 (Indirect Calorimetry)
other name: Energy intake according to REE measurements(nutrition according to the individual energy requirements)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre Singer, Professor,MD
role: Principal Investigator
affiliation: RabinMC,Beilinson Hospital
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Pierre singer
investigator title: Professor Pierre Singer, MD