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Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

Primary Purpose

Atrial Fibrillation Rapid, Postoperative Complications

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CHO (carbohydrate)
intravenous w-3 PUFA
CHO (carbohydrate) plus intravenous w3-PUFA
Sponsored by
Federal University of Mato Grosso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation Rapid

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The authors include all patients of both sexes with medical diagnose of chronic coronary heart disease and eligible to elective coronary artery bypass grafting (CABG)

Exclusion Criteria:

  • The investigators 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    No Intervention

    Arm Label

    CHO (carbohydrate) group

    W-3 PUFA group

    CHO plus intravenous w3-PUFA group

    Control

    Arm 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

    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)

    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)

    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

    Outcomes

    Primary Outcome Measures

    The incidence of postoperative atrial fibrillation (POAF)
    categorical data (patients either had or not had POAF
    The need of inotropic vasoactive drug (dobutamine and/or noradrenalin) for weaning from cardiopulmonary bypass (intraoperative period) and at ICU (postoperative period).
    categorical data (patients either need or not need vasoactive drug

    Secondary Outcome Measures

    Postoperative morbidity
    categorical data (patients either had or not had postoperative morbidity
    Length of both ICU stay
    the length in days of ICU stay
    Postoperative mortality
    categorical data (death or alive)
    Length of both hospital stay
    the length in days of hospital stay

    Full Information

    First Posted
    January 8, 2017
    Last Updated
    January 9, 2017
    Sponsor
    Federal University of Mato Grosso
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03017001
    Brief Title
    Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    October 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of Mato Grosso

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation Rapid, Postoperative Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CHO (carbohydrate) group
    Arm Type
    Experimental
    Arm 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 Title
    W-3 PUFA group
    Arm Type
    Experimental
    Arm 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 Title
    CHO plus intravenous w3-PUFA group
    Arm Type
    Experimental
    Arm 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 Title
    Control
    Arm Type
    No Intervention
    Arm 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(s)
    CHO (carbohydrate)
    Other Intervention Name(s)
    maltodextrin
    Intervention 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
    Intervention Type
    Drug
    Intervention Name(s)
    intravenous w-3 PUFA
    Other Intervention Name(s)
    w3-fatty acids
    Intervention Description
    Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA
    Intervention Type
    Other
    Intervention Name(s)
    CHO (carbohydrate) plus intravenous w3-PUFA
    Other Intervention Name(s)
    maltodextrin plus w3-fatty acids
    Intervention 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
    Primary Outcome Measure Information:
    Title
    The incidence of postoperative atrial fibrillation (POAF)
    Description
    categorical data (patients either had or not had POAF
    Time Frame
    48 hours
    Title
    The need of inotropic vasoactive drug (dobutamine and/or noradrenalin) for weaning from cardiopulmonary bypass (intraoperative period) and at ICU (postoperative period).
    Description
    categorical data (patients either need or not need vasoactive drug
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative morbidity
    Description
    categorical data (patients either had or not had postoperative morbidity
    Time Frame
    the incidence of morbidity up to 30 days after surgery
    Title
    Length of both ICU stay
    Description
    the length in days of ICU stay
    Time Frame
    number of days up to 30 days postoperatively
    Title
    Postoperative mortality
    Description
    categorical data (death or alive)
    Time Frame
    the incidence of mortality up to 30 days after surgery
    Title
    Length of both hospital stay
    Description
    the length in days of hospital stay
    Time Frame
    number of days in hospital up to 30 days postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The authors include all patients of both sexes with medical diagnose of chronic coronary heart disease and eligible to elective coronary artery bypass grafting (CABG) Exclusion Criteria: The investigators 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jose Aguilar-Nascimento, MD; PhD
    Organizational Affiliation
    Federal University of Mato Grosso
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25163472
    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.
    Results Reference
    background
    PubMed Identifier
    22729296
    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.
    Results Reference
    result
    PubMed Identifier
    27293143
    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.
    Results Reference
    result

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    Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

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