Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 8, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedJanuary 11, 2017
January 1, 2017
2.3 years
January 8, 2017
January 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
The incidence of postoperative atrial fibrillation (POAF)
categorical data (patients either had or not had POAF
48 hours
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
Secondary Outcomes (4)
Postoperative morbidity
the incidence of morbidity up to 30 days after surgery
Length of both ICU stay
number of days up to 30 days postoperatively
Postoperative mortality
the incidence of mortality up to 30 days after surgery
Length of both hospital stay
number of days in hospital up to 30 days postoperatively
Study Arms (4)
CHO (carbohydrate) group
EXPERIMENTALPatients received a 8h preoperative 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
W-3 PUFA group
EXPERIMENTALPatients received preoperative fast for solids but allowed to drink 200 mL of water until 2h before anesthesia, and an intravenous intraoperative dose of intravenous w-3-PUFA (0.2 mcg/kg)
CHO plus intravenous w3-PUFA group
EXPERIMENTALPatients 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 intravenous w-3-PUFA (0.2 mcg/kg)
Control
NO INTERVENTIONPatients received preoperative fast for solids for 8h but allowed to drink 200 mL of water until 2h before anesthesia; and no infusion of intraoperative intravenous w-3-PUFA
Interventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related 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. Epub 2014 Aug 27.
PMID: 25163472BACKGROUNDFeguri 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 Jan-Mar;27(1):7-17. doi: 10.5935/1678-9741.20120004. English, Portuguese.
PMID: 22729296RESULTLanglois PL, Hardy G, Manzanares W. Omega-3 polyunsaturated fatty acids in cardiac surgery patients: An updated systematic review and meta-analysis. Clin Nutr. 2017 Jun;36(3):737-746. doi: 10.1016/j.clnu.2016.05.013. Epub 2016 May 27.
PMID: 27293143RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Aguilar-Nascimento, MD; PhD
Federal University of Mato Grosso
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair Professor, MD, PhD
Study Record Dates
First Submitted
January 8, 2017
First Posted
January 11, 2017
Study Start
March 1, 2014
Primary Completion
June 1, 2016
Study Completion
October 1, 2016
Last Updated
January 11, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share