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REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol
INTRODUCTION: The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endp...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10660838/ https://www.ncbi.nlm.nih.gov/pubmed/37968012 http://dx.doi.org/10.1136/bmjopen-2023-075588 |
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author | Deane, Adam M Alhazzani, Waleed Guyatt, Gordon Finfer, Simon Marshall, John C Myburgh, John Zytaruk, Nicole Hardie, Miranda Saunders, Lois Knowles, Serena Lauzier, Francois Chapman, Marianne J English, Shane Muscedere, John Arabi, Yaseen Ostermann, Marlies Venkatesh, Balasubramanian Young, Paul Thabane, Lehana Billot, Laurent Heels-Ansdell, Diane Al-Fares, Abdulrahman A Hammond, Naomi E Hall, R Rajbhandari, Dorrilyn Poole, Alexis Johnson, Daniel Iqbal, Mobeen Reis, Gilmar Xie, Feng Cook, Deborah J |
author_facet | Deane, Adam M Alhazzani, Waleed Guyatt, Gordon Finfer, Simon Marshall, John C Myburgh, John Zytaruk, Nicole Hardie, Miranda Saunders, Lois Knowles, Serena Lauzier, Francois Chapman, Marianne J English, Shane Muscedere, John Arabi, Yaseen Ostermann, Marlies Venkatesh, Balasubramanian Young, Paul Thabane, Lehana Billot, Laurent Heels-Ansdell, Diane Al-Fares, Abdulrahman A Hammond, Naomi E Hall, R Rajbhandari, Dorrilyn Poole, Alexis Johnson, Daniel Iqbal, Mobeen Reis, Gilmar Xie, Feng Cook, Deborah J |
author_sort | Deane, Adam M |
collection | PubMed |
description | INTRODUCTION: The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE. METHODS AND ANALYSIS: REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial. ETHICS AND DISSEMINATION: All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide. TRIAL REGISTRATION NUMBER: NCT03374800. |
format | Online Article Text |
id | pubmed-10660838 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-106608382023-11-15 REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol Deane, Adam M Alhazzani, Waleed Guyatt, Gordon Finfer, Simon Marshall, John C Myburgh, John Zytaruk, Nicole Hardie, Miranda Saunders, Lois Knowles, Serena Lauzier, Francois Chapman, Marianne J English, Shane Muscedere, John Arabi, Yaseen Ostermann, Marlies Venkatesh, Balasubramanian Young, Paul Thabane, Lehana Billot, Laurent Heels-Ansdell, Diane Al-Fares, Abdulrahman A Hammond, Naomi E Hall, R Rajbhandari, Dorrilyn Poole, Alexis Johnson, Daniel Iqbal, Mobeen Reis, Gilmar Xie, Feng Cook, Deborah J BMJ Open Intensive Care INTRODUCTION: The Re-Evaluating the Inhibition of Stress Erosions (REVISE) Trial aims to determine the impact of the proton pump inhibitor pantoprazole compared with placebo on clinically important upper gastrointestinal (GI) bleeding in the intensive care unit (ICU), 90-day mortality and other endpoints in critically ill adults. The objective of this report is to describe the rationale, methodology, ethics and management of REVISE. METHODS AND ANALYSIS: REVISE is an international, randomised, concealed, stratified, blinded parallel-group individual patient trial being conducted in ICUs in Canada, Australia, Saudi Arabia, UK, US, Kuwait, Pakistan and Brazil. Patients≥18 years old expected to remain invasively mechanically ventilated beyond the calendar day after enrolment are being randomised to either 40 mg pantoprazole intravenously or an identical placebo daily while mechanically ventilated in the ICU. The primary efficacy outcome is clinically important upper GI bleeding within 90 days of randomisation. The primary safety outcome is 90-day all-cause mortality. Secondary outcomes include rates of ventilator-associated pneumonia, Clostridioides difficile infection, new renal replacement therapy, ICU and hospital mortality, and patient-important GI bleeding. Tertiary outcomes are total red blood cells transfused, peak serum creatinine level in the ICU, and duration of mechanical ventilation, ICU and hospital stay. The sample size is 4800 patients; one interim analysis was conducted after 2400 patients had complete 90-day follow-up; the Data Monitoring Committee recommended continuing the trial. ETHICS AND DISSEMINATION: All participating centres receive research ethics approval before initiation by hospital, region or country, including, but not limited to – Australia: Northern Sydney Local Health District Human Research Ethics Committee and Mater Misericordiae Ltd Human Research Ethics Committee; Brazil: Comissão Nacional de Ética em Pesquisa; Canada: Hamilton Integrated Research Ethics Board; Kuwait: Ministry of Health Standing Committee for Coordination of Health and Medical Research; Pakistan: Maroof Institutional Review Board; Saudi Arabia: Ministry of National Guard Health Affairs Institutional Review Board: United Kingdom: Hampshire B Research Ethics Committee; United States: Institutional Review Board of the Nebraska Medical Centre. The results of this trial will inform clinical practice and guidelines worldwide. TRIAL REGISTRATION NUMBER: NCT03374800. BMJ Publishing Group 2023-11-15 /pmc/articles/PMC10660838/ /pubmed/37968012 http://dx.doi.org/10.1136/bmjopen-2023-075588 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Intensive Care Deane, Adam M Alhazzani, Waleed Guyatt, Gordon Finfer, Simon Marshall, John C Myburgh, John Zytaruk, Nicole Hardie, Miranda Saunders, Lois Knowles, Serena Lauzier, Francois Chapman, Marianne J English, Shane Muscedere, John Arabi, Yaseen Ostermann, Marlies Venkatesh, Balasubramanian Young, Paul Thabane, Lehana Billot, Laurent Heels-Ansdell, Diane Al-Fares, Abdulrahman A Hammond, Naomi E Hall, R Rajbhandari, Dorrilyn Poole, Alexis Johnson, Daniel Iqbal, Mobeen Reis, Gilmar Xie, Feng Cook, Deborah J REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title | REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title_full | REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title_fullStr | REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title_full_unstemmed | REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title_short | REVISE: Re-Evaluating the Inhibition of Stress Erosions in the ICU: a randomised trial protocol |
title_sort | revise: re-evaluating the inhibition of stress erosions in the icu: a randomised trial protocol |
topic | Intensive Care |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10660838/ https://www.ncbi.nlm.nih.gov/pubmed/37968012 http://dx.doi.org/10.1136/bmjopen-2023-075588 |
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