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Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

Preoperative Carbohydrate Load and Intraoperative Omega-3 Polyunsaturated Fatty Acids Positively Impacts in Nosocomial Morbidity After CAGB Surgery. A Double-blind Randomized Trial.

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03017001
Enrollment
60
Registered
2017-01-11
Start date
2014-03-31
Completion date
2016-10-31
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation Rapid, Postoperative Complications

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.

Interventions

DIETARY_SUPPLEMENTCHO (carbohydrate)

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

DRUGintravenous w-3 PUFA

Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA

OTHERCHO (carbohydrate) plus 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

Sponsors

Federal University of Mato Grosso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence of postoperative atrial fibrillation (POAF)48 hourscategorical 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).48 hourscategorical data (patients either need or not need vasoactive drug

Secondary

MeasureTime frameDescription
Postoperative mortalitythe incidence of mortality up to 30 days after surgerycategorical data (death or alive)
Postoperative morbiditythe incidence of morbidity up to 30 days after surgerycategorical data (patients either had or not had postoperative morbidity
Length of both ICU staynumber of days up to 30 days postoperativelythe length in days of ICU stay
Length of both hospital staynumber of days in hospital up to 30 days postoperativelythe length in days of hospital stay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026