Postoperative Complications Clinical Trial
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.
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, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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