A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory...

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Autores principales:	Ahmad Farouk Musa, Jeswant Dillon, Mohamed Ezani Md Taib, Alwi Mohamed Yunus, Abdul Rais Sanusi, Mohd Nazeri Nordin, Julian A. Smith
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Tocovid Post-operative atrial fibrillation (POAF) CABG Length of hospital stay (LoHS) Health-related quality of life (HRQoL) Mortality Surgery RD1-811 Anesthesiology RD78.3-87.3
Acceso en línea:	https://doaj.org/article/a3c8070097bd4228b2ec567809c9cefd
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spelling	oai:doaj.org-article:a3c8070097bd4228b2ec567809c9cefd2021-11-28T12:30:57ZA double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis10.1186/s13019-021-01721-61749-8090https://doaj.org/article/a3c8070097bd4228b2ec567809c9cefd2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13019-021-01721-6https://doaj.org/toc/1749-8090Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037Ahmad Farouk MusaJeswant DillonMohamed Ezani Md TaibAlwi Mohamed YunusAbdul Rais SanusiMohd Nazeri NordinJulian A. SmithBMCarticleTocovidPost-operative atrial fibrillation (POAF)CABGLength of hospital stay (LoHS)Health-related quality of life (HRQoL)MortalitySurgeryRD1-811AnesthesiologyRD78.3-87.3ENJournal of Cardiothoracic Surgery, Vol 16, Iss 1, Pp 1-13 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Tocovid Post-operative atrial fibrillation (POAF) CABG Length of hospital stay (LoHS) Health-related quality of life (HRQoL) Mortality Surgery RD1-811 Anesthesiology RD78.3-87.3
spellingShingle	Tocovid Post-operative atrial fibrillation (POAF) CABG Length of hospital stay (LoHS) Health-related quality of life (HRQoL) Mortality Surgery RD1-811 Anesthesiology RD78.3-87.3 Ahmad Farouk Musa Jeswant Dillon Mohamed Ezani Md Taib Alwi Mohamed Yunus Abdul Rais Sanusi Mohd Nazeri Nordin Julian A. Smith A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
description	Abstract Introduction Post-operative atrial fibrillation (POAF) is associated with poorer outcomes, increased resource utilisation, morbidity and mortality. Its pathogenesis is initiated by systemic inflammation and oxidative stress. It is hypothesised that a potent antioxidant and anti-inflammatory agent such as tocotrienol, an isomer of Vitamin E, could reduce or prevent POAF. Aims The aim of this study is to determine whether a potent antioxidative and anti-inflammatory agent, Tocovid, a tocotrienol-rich capsule, could reduce the incidence of POAF and affect the mortality and morbidity as well as the duration of ICU, HDU and hospital stay. Methods This study was planned as a prospective, randomised, controlled trial with parallel groups. The control group received placebo containing palm superolein while the treatment group received Tocovid capsules. We investigated the incidence of POAF, the length of hospital stay after surgery and the health-related quality of life. Results Recruitment commenced in January 2019 but the preliminary results were unblinded as the study is still ongoing. Two-hundred and two patients have been recruited out of a target sample size of 250 as of January 2021. About 75% have completed the study and 6.4% were either lost during follow-up or withdrew; 4% of participants died. The mean age group was 61.44 ± 7.30 years with no statistical difference between the groups, with males having a preponderance for AF. The incidence of POAF was 24.36% and the mean time for developing POAF was 55.38 ± 29.9 h post-CABG. Obesity was not a predictive factor. No statistically significant difference was observed when comparing left atrial size, NYHA class, ejection fraction and the premorbid history. The mean cross-clamp time was 71 ± 34 min and the mean bypass time was 95 ± 46 min, with no difference between groups. There was a threefold increase in death among patients with POAF (p = 0.008) and an increase in the duration of ICU stay (p = 0.01), the total duration of hospital stay (p = 0.04) and reintubation (p = 0.045). Conclusion A relatively low incidence rate of POAF was noted although the study is still ongoing. It remains to be seen if our prophylactic intervention using Tocovid would effectively reduce the incidence of POAF. Clinical Registration Number: US National Library of Medicine. Clinical Trials - NCT03807037. Registered on 16th January 2019. Link: https://clinicaltrials.gov/ct2/show/NCT03807037
format	article
author	Ahmad Farouk Musa Jeswant Dillon Mohamed Ezani Md Taib Alwi Mohamed Yunus Abdul Rais Sanusi Mohd Nazeri Nordin Julian A. Smith
author_facet	Ahmad Farouk Musa Jeswant Dillon Mohamed Ezani Md Taib Alwi Mohamed Yunus Abdul Rais Sanusi Mohd Nazeri Nordin Julian A. Smith
author_sort	Ahmad Farouk Musa
title	A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
title_short	A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
title_full	A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
title_fullStr	A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
title_full_unstemmed	A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis
title_sort	double-blind randomised controlled trial on the effect of tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the national heart institute, kuala lumpur: an interim blinded analysis
publisher	BMC
publishDate	2021
url	https://doaj.org/article/a3c8070097bd4228b2ec567809c9cefd
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A double-blind randomised controlled trial on the effect of Tocovid, a tocotrienol-rich capsule on postoperative atrial fibrillation at the National Heart Institute, Kuala Lumpur: an interim blinded analysis

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