<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/NCT02985489</url>
  </required_header>
  <id_info>
    <org_study_id>REB16-2059</org_study_id>
    <nct_id>NCT02985489</nct_id>
  </id_info>
  <brief_title>Pre-Operative Parenteral Nutrition in Malnourished Patients</brief_title>
  <official_title>Preoperative PN Therapy in Malnourished Patients With IBD - A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Calgary</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will&#xD;
      have fewer post-operative complications compared to malnourished patients that receive&#xD;
      standard of care nutritional therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective To determine the impact of pre-operative PN therapy in malnourished&#xD;
      patients with IBD compared with standard of care nutritional therapy on the development of&#xD;
      total post-operative complications.&#xD;
&#xD;
      Secondary Objectives To assess the impact of pre-operative PN therapy in malnourished&#xD;
      patients with IBD compared with standard of care nutritional therapy on the incidence of&#xD;
      post-operative infectious complications Primary Endpoint The primary endpoints will be the&#xD;
      incidence of post-surgical complications in malnourished patients receiving pre-operative PN&#xD;
      therapy compared with standard of care therapy Secondary Endpoints The secondary endpoints&#xD;
      will be the cumulative incidence of post-operative infectious complications in IBD patients&#xD;
      receiving surgery and hospital length of stay in patients receiving pre-operative PN therapy&#xD;
      compared to standard of care nutritional therapy METHODS Study Design This is a prospective&#xD;
      multi-center randomized controlled study. Allocation to either intervention or control group&#xD;
      will be randomized based on blocks system (size of 4). The randomization sequence will be&#xD;
      computer generated. Conjoint Ethics Review Board Approval for the study protocol will be&#xD;
      sought in conventional manner.&#xD;
&#xD;
      Withdrawal Criteria&#xD;
&#xD;
      (a) If there is any catheter - related complications (including infection) resulting in&#xD;
      catheter removal; (b) If the patient does not meet the goal therapeutic PN rate; (c) If the&#xD;
      duration between the PN initiation and the surgery is less than 7 days (e.g. if the patient&#xD;
      needed an emergency surgical intervention)&#xD;
&#xD;
      Recruitment and Consent The overwhelming majority of patients with IBD are admitted to the&#xD;
      Gastroenterology Inpatient Service. As such, recruitment to this study will take a&#xD;
      multi-pronged approach and be stream-lined. All Gastroenterologists and Gastroenterology (GI)&#xD;
      Fellows in training at the FMC and PLC will be made aware of the protocol and as they are&#xD;
      rounding, they will be aware to ask any eligible patients if they would be willing to speak&#xD;
      with our research assistant about study participation. In addition, the research coordinator&#xD;
      assigned to the study will review the inpatient electronic medical record, Sunrise Clinical&#xD;
      Manager (SCM) daily to identify newly admitted inpatients to both study sites with IBD. The&#xD;
      research coordinator will review the study eligibility of the newly admitted inpatients with&#xD;
      the GI Fellows rotating on the GI service, and approach patients for protocol review and&#xD;
      consent once deemed eligible. All participants will undergo prospective consenting via a&#xD;
      written informed consent either by themselves or their family members.&#xD;
&#xD;
      Study Intervention Experimental Group Participants assigned to the experimental group will&#xD;
      commence PN therapy delivered through central venous catheter (CVC) access within 24-48 hours&#xD;
      of admission. For the study, Olimel will be used as the PN formulation of choice.&#xD;
      Specifically, Olimel 5.7% with electrolytes will be the preferred study product. CVC access&#xD;
      is readily obtained at the FMC and PLC within this duration through a central venous access&#xD;
      team designated team for this purpose. A registered dietitian (RD) will be specifically&#xD;
      recruited for this study and will prescribe PN for eligible patients based on individualized&#xD;
      nutritional assessment. Eligible patients will be malnourished by definition, resulting in&#xD;
      conservative initial PN dosing to minimize the risk of refeeding syndrome . The study RD will&#xD;
      calculate energy requirements based on predictive equations, such as the Harris Benedict&#xD;
      Equation to determine target goals. The target protein and calorie requirements will be met&#xD;
      within 48-72 hours of PN initiation. The optimal duration of delivery of PN preoperatively&#xD;
      was defined by Klein et al , supported by an earlier meta-analysis by Detsky et al. The Klein&#xD;
      meta-analysis of 14 prospective randomized trials showed a consistent benefit from&#xD;
      preoperative PN, showing a 10% reduction in overall postoperative complications. Thirteen of&#xD;
      14 studies in this meta-analysis provided PN for at least 7 days , leading the Klein&#xD;
      suggestions that use of PN should not be considered unless the duration of therapy was&#xD;
      anticipated to be a minimum of 7 days. In accordance, PN will be administered for a minimum&#xD;
      of 7-days prior to surgery.&#xD;
&#xD;
      Control Group Participants assigned to the control group will receive standard of care (SOC)&#xD;
      nutritional therapy. Control group patients will be assessed by the RD assigned to the&#xD;
      medical unit to which the patient has been admitted (independent RD assessment). The unit RD&#xD;
      will follow standard nutrition screening processes to determine nutrition risk, followed by a&#xD;
      complete nutrition assessment in the presence of nutrition risk. Conventionally, patients&#xD;
      will complete calorie counts with clinical observation by the unit RD, with nutrition&#xD;
      support, typically enteral nutrition recommended when oral intake is inadequate. Failure of&#xD;
      EN to meet goal calorie intake may result in PN therapy at the discretion of the unit RD and&#xD;
      treating team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No patients recruited&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>incidence of post-surgical complications in malnourished patients receiving pre-operative PN therapy compared with standard of care therapy</measure>
    <time_frame>From date of randomization until the date of hospital discharge, assessed up to 6 months</time_frame>
    <description>To determine the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the development of total post-operative complications.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cumulative incidence of post-operative infectious complications in IBD patients receiving surgery</measure>
    <time_frame>From date of randomization until the date of hospital discharge, assessed up to 6 months</time_frame>
    <description>To assess the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the incidence of post-operative infectious complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Malnutrition</condition>
  <condition>Inflammatory Bowel Disease 1</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants assigned to the experimental group will commence Olimel Parenteral Nutrition therapy delivered through central venous catheter (CVC) access within 24-48 hours of admission.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to the control group will receive standard of care (SOC) nutritional therapy. Control group patients will be assessed by the RD assigned to the medical unit to which the patient has been admitted (independent RD assessment). The unit RD will follow standard nutrition screening processes to determine nutrition risk, followed by a complete nutrition assessment in the presence of nutrition risk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Olimel Parenteral Nutrition</intervention_name>
    <description>Olimel 5.7% with electrolytes</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (a) Age &gt; 18 years;&#xD;
&#xD;
          -  (b) Ability to provide informed consent;&#xD;
&#xD;
          -  (c) Documented diagnosis of IBD as confirmed in the patient chart;&#xD;
&#xD;
          -  (d) Malnourished status as defined by SGA B or C status;&#xD;
&#xD;
          -  (e)Referral to colorectal surgery for surgical assessment;&#xD;
&#xD;
          -  (f) No major contraindications to PN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) Active sepsis defined by positive blood cultures or fever &gt; 38.5 within 48 hours&#xD;
             of PN initiation;&#xD;
&#xD;
          -  (b)Well-nourished status defined as SGA-A;&#xD;
&#xD;
          -  (c) Inadequate vascular access;&#xD;
&#xD;
          -  (d) Advanced liver disease;&#xD;
&#xD;
          -  (e)Poorly controlled blood sugars&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maitreyi Raman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</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>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02985489
org study id: REB16-2059
nct id: NCT02985489
lead sponsor: 
has dmc: No
Malnourished patients with IBD that receive pre-operative parenteral nutrition therapy will
      have fewer post-operative complications compared to malnourished patients that receive
      standard of care nutritional therapy.
Primary Objective To determine the impact of pre-operative PN therapy in malnourished
      patients with IBD compared with standard of care nutritional therapy on the development of
      total post-operative complications.

      Secondary Objectives To assess the impact of pre-operative PN therapy in malnourished
      patients with IBD compared with standard of care nutritional therapy on the incidence of
      post-operative infectious complications Primary Endpoint The primary endpoints will be the
      incidence of post-surgical complications in malnourished patients receiving pre-operative PN
      therapy compared with standard of care therapy Secondary Endpoints The secondary endpoints
      will be the cumulative incidence of post-operative infectious complications in IBD patients
      receiving surgery and hospital length of stay in patients receiving pre-operative PN therapy
      compared to standard of care nutritional therapy METHODS Study Design This is a prospective
      multi-center randomized controlled study. Allocation to either intervention or control group
      will be randomized based on blocks system (size of 4). The randomization sequence will be
      computer generated. Conjoint Ethics Review Board Approval for the study protocol will be
      sought in conventional manner.

      Withdrawal Criteria

      (a) If there is any catheter - related complications (including infection) resulting in
      catheter removal; (b) If the patient does not meet the goal therapeutic PN rate; (c) If the
      duration between the PN initiation and the surgery is less than 7 days (e.g. if the patient
      needed an emergency surgical intervention)

      Recruitment and Consent The overwhelming majority of patients with IBD are admitted to the
      Gastroenterology Inpatient Service. As such, recruitment to this study will take a
      multi-pronged approach and be stream-lined. All Gastroenterologists and Gastroenterology (GI)
      Fellows in training at the FMC and PLC will be made aware of the protocol and as they are
      rounding, they will be aware to ask any eligible patients if they would be willing to speak
      with our research assistant about study participation. In addition, the research coordinator
      assigned to the study will review the inpatient electronic medical record, Sunrise Clinical
      Manager (SCM) daily to identify newly admitted inpatients to both study sites with IBD. The
      research coordinator will review the study eligibility of the newly admitted inpatients with
      the GI Fellows rotating on the GI service, and approach patients for protocol review and
      consent once deemed eligible. All participants will undergo prospective consenting via a
      written informed consent either by themselves or their family members.

      Study Intervention Experimental Group Participants assigned to the experimental group will
      commence PN therapy delivered through central venous catheter (CVC) access within 24-48 hours
      of admission. For the study, Olimel will be used as the PN formulation of choice.
      Specifically, Olimel 5.7% with electrolytes will be the preferred study product. CVC access
      is readily obtained at the FMC and PLC within this duration through a central venous access
      team designated team for this purpose. A registered dietitian (RD) will be specifically
      recruited for this study and will prescribe PN for eligible patients based on individualized
      nutritional assessment. Eligible patients will be malnourished by definition, resulting in
      conservative initial PN dosing to minimize the risk of refeeding syndrome . The study RD will
      calculate energy requirements based on predictive equations, such as the Harris Benedict
      Equation to determine target goals. The target protein and calorie requirements will be met
      within 48-72 hours of PN initiation. The optimal duration of delivery of PN preoperatively
      was defined by Klein et al , supported by an earlier meta-analysis by Detsky et al. The Klein
      meta-analysis of 14 prospective randomized trials showed a consistent benefit from
      preoperative PN, showing a 10% reduction in overall postoperative complications. Thirteen of
      14 studies in this meta-analysis provided PN for at least 7 days , leading the Klein
      suggestions that use of PN should not be considered unless the duration of therapy was
      anticipated to be a minimum of 7 days. In accordance, PN will be administered for a minimum
      of 7-days prior to surgery.

      Control Group Participants assigned to the control group will receive standard of care (SOC)
      nutritional therapy. Control group patients will be assessed by the RD assigned to the
      medical unit to which the patient has been admitted (independent RD assessment). The unit RD
      will follow standard nutrition screening processes to determine nutrition risk, followed by a
      complete nutrition assessment in the presence of nutrition risk. Conventionally, patients
      will complete calorie counts with clinical observation by the unit RD, with nutrition
      support, typically enteral nutrition recommended when oral intake is inadequate. Failure of
      EN to meet goal calorie intake may result in PN therapy at the discretion of the unit RD and
      treating team.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: incidence of post-surgical complications in malnourished patients receiving pre-operative PN therapy compared with standard of care therapy
time frame: From date of randomization until the date of hospital discharge, assessed up to 6 months
description: To determine the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the development of total post-operative complications.
measure: cumulative incidence of post-operative infectious complications in IBD patients receiving surgery
time frame: From date of randomization until the date of hospital discharge, assessed up to 6 months
description: To assess the impact of pre-operative PN therapy in malnourished patients with IBD compared with standard of care nutritional therapy on the incidence of post-operative infectious complications
arm group label: Experimental Group
arm group type: Experimental
description: Participants assigned to the experimental group will commence Olimel Parenteral Nutrition therapy delivered through central venous catheter (CVC) access within 24-48 hours of admission.
arm group label: Control Group
arm group type: No Intervention
description: Participants assigned to the control group will receive standard of care (SOC) nutritional therapy. Control group patients will be assessed by the RD assigned to the medical unit to which the patient has been admitted (independent RD assessment). The unit RD will follow standard nutrition screening processes to determine nutrition risk, followed by a complete nutrition assessment in the presence of nutrition risk.
intervention type: Dietary Supplement
intervention name: Olimel Parenteral Nutrition
description: Olimel 5.7% with electrolytes
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Maitreyi Raman, MD
role: Principal Investigator
affiliation: University of Calgary
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
mesh term: Crohn Disease
mesh term: Malnutrition
sharing ipd: No