<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/NCT03017001</url>
  </required_header>
  <id_info>
    <org_study_id>30493514.5.000.5165</org_study_id>
    <nct_id>NCT03017001</nct_id>
  </id_info>
  <brief_title>Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery</brief_title>
  <official_title>Preoperative Carbohydrate Load and Intraoperative Omega-3 Polyunsaturated Fatty Acids Positively Impacts in Nosocomial Morbidity After CAGB Surgery. A Double-blind Randomized Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Mato Grosso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Mato Grosso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Omega-3 polyunsaturated fatty acids (w-3-PUFA) may have a potential role in enhance the&#xD;
      postoperative balance of host immunity and reduce the incidence of postoperative atrial&#xD;
      fibrillation (POAF). CHO drinks 2h before the induction of the anesthesia may reduce the&#xD;
      necessity of vasoactive drugs preoperatively. the aim of this study was to investigate the&#xD;
      effect of these two nutrients in patients undergoing CABG with cardiopulmonary bypass (CPB)&#xD;
      on morbidity at ICU, mainly POFA. This is a double-blind controlled randomized trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The authors include all patients of both sexes with medical diagnose of chronic coronary&#xD;
      heart disease and eligible to elective CABG with age ranging from 18 to 80 years. All&#xD;
      patients have signed the written informed consent form. We exclude those who have&#xD;
      insulin-dependent diabetic, hepatic or renal disorders, thrombocytopenia, important&#xD;
      dyslipidemia (triglycerides 3-fold higher than normal standard), gastro-esophageal reflux,&#xD;
      acute coronary syndromes, allergy to fish oil, and severe malnutrition. We also exclude&#xD;
      patients underwent off-pump CABG, combined heart procedures, reoperations, and those who&#xD;
      received blood transfusion in the last 3 months.&#xD;
&#xD;
      Patients were randomized using a random number software available at www.graphpad.com . They&#xD;
      were allocated for four groups: group CHO (patients received a 8h fast for solids and 2h fast&#xD;
      with 200mL of a drink containing water plus 12.5% maltodextrin (25g) and no infusion of&#xD;
      intraoperative w-3-PUFA); Control group (preoperative fast for solids for 8h but allowed to&#xD;
      drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative&#xD;
      w-3-PUFA); group CHO+w3 (patients received a 8h fast for solids and 2h fast with 200mL of a&#xD;
      drink containing water plus 12.5% maltodextrin (25g), and an intravenous intraoperative dose&#xD;
      of w-3-PUFA (0.2 mcg/kg) during 4h ); and group w3 (preoperative fast for solids but allowed&#xD;
      to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose&#xD;
      of w-3-PUFA (0.2 mcg/kg) during 4h).&#xD;
&#xD;
      Only a dietitian of the hospital knew the randomization chart and informed the ward nurse to&#xD;
      give the patient one of the two preoperative drinks before sent him to the surgical theater.&#xD;
      . She also informed the anesthesiologist which patient would receive the intraoperative&#xD;
      w-3-PUFA. The surgeon and his assistant team did not know which group belong each patient. A&#xD;
      team of cardiologists and intensivists who also were blind to the study design and&#xD;
      randomization collected all data.&#xD;
&#xD;
      Endpoints The primary endpoints were the incidence of POAF and the need of inotropic&#xD;
      vasoactive drug (dobutamine and/or noradrenalin) for weaning from CPB (intraoperative period)&#xD;
      and at ICU (postoperative period). As secondary endpoints the investigators looked at&#xD;
      perioperative morbidity, hospital mortality and length of both ICU stay and total&#xD;
      postoperative stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of postoperative atrial fibrillation (POAF)</measure>
    <time_frame>48 hours</time_frame>
    <description>categorical data (patients either had or not had POAF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The need of inotropic vasoactive drug (dobutamine and/or noradrenalin) for weaning from cardiopulmonary bypass (intraoperative period) and at ICU (postoperative period).</measure>
    <time_frame>48 hours</time_frame>
    <description>categorical data (patients either need or not need vasoactive drug</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative morbidity</measure>
    <time_frame>the incidence of morbidity up to 30 days after surgery</time_frame>
    <description>categorical data (patients either had or not had postoperative morbidity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of both ICU stay</measure>
    <time_frame>number of days up to 30 days postoperatively</time_frame>
    <description>the length in days of ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality</measure>
    <time_frame>the incidence of mortality up to 30 days after surgery</time_frame>
    <description>categorical data (death or alive)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of both hospital stay</measure>
    <time_frame>number of days in hospital up to 30 days postoperatively</time_frame>
    <description>the length in days of hospital stay</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Atrial Fibrillation Rapid</condition>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>CHO (carbohydrate) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a 8h preoperative fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g) and no infusion of intraoperative w-3-PUFA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>W-3 PUFA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received preoperative fast for solids but allowed to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CHO plus intravenous w3-PUFA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients received a 8h fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g), and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients received preoperative fast for solids for 8h but allowed to drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative intravenous w-3-PUFA</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CHO (carbohydrate)</intervention_name>
    <description>Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia</description>
    <arm_group_label>CHO (carbohydrate) group</arm_group_label>
    <other_name>maltodextrin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravenous w-3 PUFA</intervention_name>
    <description>Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA</description>
    <arm_group_label>W-3 PUFA group</arm_group_label>
    <other_name>w3-fatty acids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CHO (carbohydrate) plus intravenous w3-PUFA</intervention_name>
    <description>Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia, plus an intravenous dose of w3-PUFA intraoperatively</description>
    <arm_group_label>CHO plus intravenous w3-PUFA group</arm_group_label>
    <other_name>maltodextrin plus w3-fatty acids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The authors include all patients of both sexes with medical diagnose of chronic&#xD;
             coronary heart disease and eligible to elective coronary artery bypass grafting (CABG)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The investigators exclude those who have insulin-dependent diabetic, hepatic or renal&#xD;
             disorders, thrombocytopenia, important dyslipidemia (triglycerides 3-fold higher than&#xD;
             normal standard), gastro-esophageal reflux, acute coronary syndromes, allergy to fish&#xD;
             oil, and severe malnutrition. We also exclude patients underwent off-pump CABG,&#xD;
             combined heart procedures, reoperations, and those who received blood transfusion in&#xD;
             the last 3 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Aguilar-Nascimento, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Mato Grosso</affiliation>
  </overall_official>
  <reference>
    <citation>Aguilar-Nascimento JE, Feguri GR. Fasting may not be required before percutaneous coronary intervention. Evid Based Nurs. 2015 Apr;18(2):41. doi: 10.1136/eb-2014-101904. Epub 2014 Aug 27.</citation>
    <PMID>25163472</PMID>
  </reference>
  <results_reference>
    <citation>Feguri GR, Lima PR, Lopes AM, Roledo A, Marchese M, Trevisan M, Ahmad H, Freitas BB, Aguilar-Nascimento JE. Clinical and metabolic results of fasting abbreviation with carbohydrates in coronary artery bypass graft surgery. Rev Bras Cir Cardiovasc. 2012 Jan-Mar;27(1):7-17. doi: 10.5935/1678-9741.20120004. English, Portuguese.</citation>
    <PMID>22729296</PMID>
  </results_reference>
  <results_reference>
    <citation>Langlois PL, Hardy G, Manzanares W. Omega-3 polyunsaturated fatty acids in cardiac surgery patients: An updated systematic review and meta-analysis. Clin Nutr. 2017 Jun;36(3):737-746. doi: 10.1016/j.clnu.2016.05.013. Epub 2016 May 27.</citation>
    <PMID>27293143</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Mato Grosso</investigator_affiliation>
    <investigator_full_name>Jose Eduardo de Aguilar-Nascimento</investigator_full_name>
    <investigator_title>Chair Professor, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Postoperative Complications</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/NCT03017001
org study id: 30493514.5.000.5165
nct id: NCT03017001
lead sponsor: 
has dmc: No
Omega-3 polyunsaturated fatty acids (w-3-PUFA) may have a potential role in enhance the
      postoperative balance of host immunity and reduce the incidence of postoperative atrial
      fibrillation (POAF). CHO drinks 2h before the induction of the anesthesia may reduce the
      necessity of vasoactive drugs preoperatively. the aim of this study was to investigate the
      effect of these two nutrients in patients undergoing CABG with cardiopulmonary bypass (CPB)
      on morbidity at ICU, mainly POFA. This is a double-blind controlled randomized trial.
The authors include all patients of both sexes with medical diagnose of chronic coronary
      heart disease and eligible to elective CABG with age ranging from 18 to 80 years. All
      patients have signed the written informed consent form. We exclude those who have
      insulin-dependent diabetic, hepatic or renal disorders, thrombocytopenia, important
      dyslipidemia (triglycerides 3-fold higher than normal standard), gastro-esophageal reflux,
      acute coronary syndromes, allergy to fish oil, and severe malnutrition. We also exclude
      patients underwent off-pump CABG, combined heart procedures, reoperations, and those who
      received blood transfusion in the last 3 months.

      Patients were randomized using a random number software available at www.graphpad.com . They
      were allocated for four groups: group CHO (patients received a 8h fast for solids and 2h fast
      with 200mL of a drink containing water plus 12.5% maltodextrin (25g) and no infusion of
      intraoperative w-3-PUFA); Control group (preoperative fast for solids for 8h but allowed to
      drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative
      w-3-PUFA); group CHO+w3 (patients received a 8h fast for solids and 2h fast with 200mL of a
      drink containing water plus 12.5% maltodextrin (25g), and an intravenous intraoperative dose
      of w-3-PUFA (0.2 mcg/kg) during 4h ); and group w3 (preoperative fast for solids but allowed
      to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose
      of w-3-PUFA (0.2 mcg/kg) during 4h).

      Only a dietitian of the hospital knew the randomization chart and informed the ward nurse to
      give the patient one of the two preoperative drinks before sent him to the surgical theater.
      . She also informed the anesthesiologist which patient would receive the intraoperative
      w-3-PUFA. The surgeon and his assistant team did not know which group belong each patient. A
      team of cardiologists and intensivists who also were blind to the study design and
      randomization collected all data.

      Endpoints The primary endpoints were the incidence of POAF and the need of inotropic
      vasoactive drug (dobutamine and/or noradrenalin) for weaning from CPB (intraoperative period)
      and at ICU (postoperative period). As secondary endpoints the investigators looked at
      perioperative morbidity, hospital mortality and length of both ICU stay and total
      postoperative stay.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The incidence of postoperative atrial fibrillation (POAF)
time frame: 48 hours
description: categorical data (patients either had or not had POAF
measure: The need of inotropic vasoactive drug (dobutamine and/or noradrenalin) for weaning from cardiopulmonary bypass (intraoperative period) and at ICU (postoperative period).
time frame: 48 hours
description: categorical data (patients either need or not need vasoactive drug
measure: Postoperative morbidity
time frame: the incidence of morbidity up to 30 days after surgery
description: categorical data (patients either had or not had postoperative morbidity
measure: Length of both ICU stay
time frame: number of days up to 30 days postoperatively
description: the length in days of ICU stay
measure: Postoperative mortality
time frame: the incidence of mortality up to 30 days after surgery
description: categorical data (death or alive)
measure: Length of both hospital stay
time frame: number of days in hospital up to 30 days postoperatively
description: the length in days of hospital stay
arm group label: CHO (carbohydrate) group
arm group type: Experimental
description: Patients received a 8h preoperative fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g) and no infusion of intraoperative w-3-PUFA
arm group label: W-3 PUFA group
arm group type: Experimental
description: Patients received preoperative fast for solids but allowed to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)
arm group label: CHO plus intravenous w3-PUFA group
arm group type: Experimental
description: Patients received a 8h fast for solids and 2h fast with 200mL of a drink containing water plus 12.5% maltodextrin (25g), and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)
arm group label: Control
arm group type: No Intervention
description: Patients received preoperative fast for solids for 8h but allowed to drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative intravenous w-3-PUFA
intervention type: Dietary Supplement
intervention name: CHO (carbohydrate)
description: Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia
arm group label: CHO (carbohydrate) group
other name: maltodextrin
intervention type: Drug
intervention name: intravenous w-3 PUFA
description: Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA
arm group label: W-3 PUFA group
other name: w3-fatty acids
intervention type: Other
intervention name: CHO (carbohydrate) plus intravenous w3-PUFA
description: Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia, plus an intravenous dose of w3-PUFA intraoperatively
arm group label: CHO plus intravenous w3-PUFA group
other name: maltodextrin plus w3-fatty acids
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jose Aguilar-Nascimento, MD; PhD
role: Principal Investigator
affiliation: Federal University of Mato Grosso
citation: Aguilar-Nascimento JE, Feguri GR. Fasting may not be required before percutaneous coronary intervention. Evid Based Nurs. 2015 Apr;18(2):41. doi: 10.1136/eb-2014-101904. Epub 2014 Aug 27.
PMID: 25163472
citation: Feguri GR, Lima PR, Lopes AM, Roledo A, Marchese M, Trevisan M, Ahmad H, Freitas BB, Aguilar-Nascimento JE. Clinical and metabolic results of fasting abbreviation with carbohydrates in coronary artery bypass graft surgery. Rev Bras Cir Cardiovasc. 2012 Jan-Mar;27(1):7-17. doi: 10.5935/1678-9741.20120004. English, Portuguese.
PMID: 22729296
citation: Langlois PL, Hardy G, Manzanares W. Omega-3 polyunsaturated fatty acids in cardiac surgery patients: An updated systematic review and meta-analysis. Clin Nutr. 2017 Jun;36(3):737-746. doi: 10.1016/j.clnu.2016.05.013. Epub 2016 May 27.
PMID: 27293143
responsible party type: Principal Investigator
investigator affiliation: Federal University of Mato Grosso
investigator full name: Jose Eduardo de Aguilar-Nascimento
investigator title: Chair Professor, MD, PhD
mesh term: Atrial Fibrillation
mesh term: Postoperative Complications
sharing ipd: No