<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/NCT04464161</url>
  </required_header>
  <id_info>
    <org_study_id>20-00748</org_study_id>
    <nct_id>NCT04464161</nct_id>
  </id_info>
  <brief_title>The Effects of Perioperative Nutritional Optimization on Blood Markers</brief_title>
  <official_title>The Effects of Perioperative Nutritional Optimization on Blood Markers of Nutritional Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</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 purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition&#xD;
      Shake) before and after lumbar spine surgery affects blood tests related the nutritional&#xD;
      status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine&#xD;
      surgery are at increased risk for complications and longer hospitalizations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will examine whether a simple and cost-effective perioperative nutritional program&#xD;
      will affect blood markers of nutritional status (albumin, pre-albumin, transferrin,&#xD;
      electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our&#xD;
      institution by a single surgeon and meet all inclusion criteria will be added to this study.&#xD;
      Patients will be randomized into one of two arms; the interventional group will be provide&#xD;
      with daily Ensure protein drinks for two weeks pre-operatively and four weeks&#xD;
      post-operatively, while the control group will be instructed to continue their current diet&#xD;
      plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin,&#xD;
      electrolyes) will be obtained to assess objective differences in nutritional status.&#xD;
&#xD;
      N/A&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 20, 2020</start_date>
  <completion_date type="Actual">August 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 19, 2021</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in blood markers in patients</measure>
    <time_frame>Baseline, 4 weeks post-operative visit</time_frame>
    <description>Nutritional status of patients undergoing lumbar surgery will be measured by their blood markers. T-tests with a p value of 0.05 will be used for these tests. Chi square and t-tests will be used.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Intervertebral Disc Disorders With Radiculopathy, Lumbar Region</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment arm will receive 6 week supply of daily Ensure protein drinks, while the control arm will be instructed to continue their current diet. This includes 2 weeks pre-operatively and 4 weeks post-operatively.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will be instructed to continue to their regular diets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ensure</intervention_name>
    <description>Ensure protein is a complete nutritional drink with 10g, 240 calories, and 27 vitamins and minerals. It is often used as a nutritional supplementation in many hospitals.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 55 years and older undergoing primary lumbar spine surgery for the&#xD;
             treatment of radiculopathy and other lumbar pathologies&#xD;
&#xD;
          -  Patients have the willingness and ability to participate in a study procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are younger than 55 years old&#xD;
&#xD;
          -  Patients undergoing revision surgery&#xD;
&#xD;
          -  Patients undergoing surgery due to trauma/fractures&#xD;
&#xD;
          -  Patients with lactose intolerance&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Passias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Hleath</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>June 16, 2022</last_update_submitted>
  <last_update_submitted_qc>June 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2022</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>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Hesham.saleh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04464161
org study id: 20-00748
nct id: NCT04464161
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see if taking an oral nutrition supplement (Ensure Nutrition
      Shake) before and after lumbar spine surgery affects blood tests related the nutritional
      status of patients. Patients with poor nutritional statuses who undergo elective lumbar spine
      surgery are at increased risk for complications and longer hospitalizations.
The study will examine whether a simple and cost-effective perioperative nutritional program
      will affect blood markers of nutritional status (albumin, pre-albumin, transferrin,
      electrolytes). All patients 55 years and older who are undergoing lumbar spine surgery at our
      institution by a single surgeon and meet all inclusion criteria will be added to this study.
      Patients will be randomized into one of two arms; the interventional group will be provide
      with daily Ensure protein drinks for two weeks pre-operatively and four weeks
      post-operatively, while the control group will be instructed to continue their current diet
      plans. Four weeks post-operatively, blood markers (serum albumin, pre-albumin, transferrin,
      electrolyes) will be obtained to assess objective differences in nutritional status.

      N/A
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Difference in blood markers in patients
time frame: Baseline, 4 weeks post-operative visit
description: Nutritional status of patients undergoing lumbar surgery will be measured by their blood markers. T-tests with a p value of 0.05 will be used for these tests. Chi square and t-tests will be used.
arm group label: Arm 1
arm group type: Experimental
description: The treatment arm will receive 6 week supply of daily Ensure protein drinks, while the control arm will be instructed to continue their current diet. This includes 2 weeks pre-operatively and 4 weeks post-operatively.
arm group label: Arm 2
arm group type: No Intervention
description: The control group will be instructed to continue to their regular diets.
intervention type: Dietary Supplement
intervention name: Ensure
description: Ensure protein is a complete nutritional drink with 10g, 240 calories, and 27 vitamins and minerals. It is often used as a nutritional supplementation in many hospitals.
arm group label: Arm 1
criteria: 
gender: All
minimum age: 55 Years
maximum age: 100 Years
healthy volunteers: No
last name: Peter Passias, MD
role: Principal Investigator
affiliation: NYU Langone Hleath
facility: 
country: United States
responsible party type: Sponsor
mesh term: Radiculopathy
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Hesham.saleh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.