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Atrial Fibrillation RapidPhase 2/3NCT03017001

Preoperative Carbohydrate Load and Intraoperative w3-PUFA in CAGB Surgery

A Phase 2/3 study testing CHO (carbohydrate), intravenous w-3 PUFA and CHO (carbohydrate) plus intravenous w3-PUFA in people with Atrial Fibrillation Rapid and Postoperative Complications, run by Federal University of Mato Grosso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
CHO (carbohydrate), intravenous w-3 PUFA and CHO (carbohydrate) plus intravenous w3-PUFA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
Mar 2014to Oct 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

About this study

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.

Read the 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.

Being tested
CHO (carbohydrate), intravenous w-3 PUFA, CHO (carbohydrate) plus intravenous w3-PUFA
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHO (carbohydrate)Dietary supplement

    Also called maltodextrin

    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

  • intravenous w-3 PUFADrug

    Also called w3-fatty acids

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

  • CHO (carbohydrate) plus intravenous w3-PUFAOther

    Also called maltodextrin plus w3-fatty acids

    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

Study groups in NCT03017001
Study groupRoleWhat they receive
CHO (carbohydrate) groupExperimentalPatients 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
Receives: Dietary Supplement: CHO (carbohydrate)
W-3 PUFA groupExperimentalPatients 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)
Receives: Drug: intravenous w-3 PUFA
CHO plus intravenous w3-PUFA groupExperimentalPatients 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)
Receives: Other: CHO (carbohydrate) plus intravenous w3-PUFA
ControlNo 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of postoperative atrial fibrillation (POAF)

    categorical data (patients either had or not had POAF

    Measured: 48 hours

  2. 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

    Measured: 48 hours

Secondary outcomes (4)

  1. Postoperative morbidity

    categorical data (patients either had or not had postoperative morbidity

    Measured: the incidence of morbidity up to 30 days after surgery

  2. Length of both ICU stay

    the length in days of ICU stay

    Measured: number of days up to 30 days postoperatively

  3. Postoperative mortality

    categorical data (death or alive)

    Measured: the incidence of mortality up to 30 days after surgery

  4. Length of both hospital stay

    the length in days of hospital stay

    Measured: number of days in hospital up to 30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study startMar 2014
  3. Primary completionJun 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017001
Sponsor's protocol ID
30493514.5.000.5165
Status last verified
Jan 2017
First submitted
8 Jan 2017
Last updated
11 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25163472

  • 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 Jan-Mar;27(1):7-17. doi: 10.5935/1678-9741.20120004. English, Portuguese.

    PubMed 22729296

  • Langlois 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.

    PubMed 27293143

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CHO (carbohydrate), intravenous w-3 PUFA and CHO (carbohydrate) plus intravenous w3-PUFA in people with Atrial Fibrillation Rapid and Postoperative Complications, run by Federal University of Mato Grosso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of postoperative atrial fibrillation (POAF) (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017001, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.

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