Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery
Condition: Atrial Fibrillation Rapid; Postoperative Complications
MeSH terms: Atrial Fibrillation; Postoperative Complications
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): CHO (carbohydrate); intravenous w-3 PUFA; CHO (carbohydrate) plus intravenous w3-PUFA
Intervention type(s): Dietary Supplement; Drug; Other
Intervention description(s): 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; Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA; 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
Other intervention name(s): maltodextrin; w3-fatty acids; maltodextrin plus w3-fatty acids
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention