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Completed

NCT Number: NCT03017001

Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHO (carbohydrate)

Dietary Supplement

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

Other names: maltodextrin

intravenous w-3 PUFA

Drug

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

Other names: w3-fatty acids

CHO (carbohydrate) plus intravenous w3-PUFA

Other

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 names: maltodextrin plus w3-fatty acids

Primary outcomes

  1. The incidence of postoperative atrial fibrillation (POAF)

    Time frame: 48 hours

    categorical data (patients either had or not had POAF

  2. 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

    categorical data (patients either need or not need vasoactive drug

Secondary outcomes

  1. Postoperative morbidity

    Time frame: the incidence of morbidity up to 30 days after surgery

    categorical data (patients either had or not had postoperative morbidity

  2. Length of both ICU stay

    Time frame: number of days up to 30 days postoperatively

    the length in days of ICU stay

  3. Postoperative mortality

    Time frame: the incidence of mortality up to 30 days after surgery

    categorical data (death or alive)

  4. Length of both hospital stay

    Time frame: number of days in hospital up to 30 days postoperatively

    the length in days of hospital stay

Sponsors and collaborators

Lead sponsor

Federal University of Mato Grosso

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 11, 2017
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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