Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017001
• Other study ID #: 30493514.5.000.5165
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 8, 2017
• Last updated: January 9, 2017
• Start date: March 2014
• Est. completion date: October 2016

Study information

• Verified date: January 2017
• Source: Federal University of Mato Grosso do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Rapid
• Postoperative Complications

Intervention

Dietary Supplement:
• CHO (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

Drug:
• intravenous w-3 PUFA
Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA

Other:
• CHO (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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Mato Grosso do Sul

References & Publications (3)

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. — View 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 Ja — View 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. 2016 May 27. pii: S0261-5614(16)30109-1. doi: 10.1016/j.clnu.2016.05.013. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative atrial fibrillation (POAF)	categorical data (patients either had or not had POAF	48 hours	No
Primary	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	48 hours	No
Secondary	Postoperative morbidity	categorical data (patients either had or not had postoperative morbidity	the incidence of morbidity up to 30 days after surgery	No
Secondary	Length of both ICU stay	the length in days of ICU stay	number of days up to 30 days postoperatively	No
Secondary	Postoperative mortality	categorical data (death or alive)	the incidence of mortality up to 30 days after surgery	No
Secondary	Length of both hospital stay	the length in days of hospital stay	number of days in hospital up to 30 days postoperatively	No