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Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial

INTRODUCTION: Delirium is a major public health issue for surgical patients and their families because it is associated with increased mortality, cognitive and functional decline, prolonged hospital admission and increased healthcare expenditures. Based on preliminary data, this trial tests the hypo...

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Autores principales: Vlisides, Phillip E, Ragheb, Jacqueline, McKinney, Amy, Mentz, Graciela, Runstadler, Nathan, Martinez, Selena, Jewell, Elizabeth, Lee, UnCheol, Vanini, Giancarlo, Schmitt, Eva M, Inouye, Sharon K, Mashour, George A
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10186430/
https://www.ncbi.nlm.nih.gov/pubmed/37188468
http://dx.doi.org/10.1136/bmjopen-2023-073945
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author Vlisides, Phillip E
Ragheb, Jacqueline
McKinney, Amy
Mentz, Graciela
Runstadler, Nathan
Martinez, Selena
Jewell, Elizabeth
Lee, UnCheol
Vanini, Giancarlo
Schmitt, Eva M
Inouye, Sharon K
Mashour, George A
author_facet Vlisides, Phillip E
Ragheb, Jacqueline
McKinney, Amy
Mentz, Graciela
Runstadler, Nathan
Martinez, Selena
Jewell, Elizabeth
Lee, UnCheol
Vanini, Giancarlo
Schmitt, Eva M
Inouye, Sharon K
Mashour, George A
author_sort Vlisides, Phillip E
collection PubMed
description INTRODUCTION: Delirium is a major public health issue for surgical patients and their families because it is associated with increased mortality, cognitive and functional decline, prolonged hospital admission and increased healthcare expenditures. Based on preliminary data, this trial tests the hypothesis that intravenous caffeine, given postoperatively, will reduce the incidence of delirium in older adults after major non-cardiac surgery. METHODS AND ANALYSIS: The CAffeine, Postoperative Delirium And CHange In Outcomes after Surgery-2 (CAPACHINOS-2) Trial is a single-centre, placebo-controlled, randomised clinical trial that will be conducted at Michigan Medicine. The trial will be quadruple-blinded, with clinicians, researchers, participants and analysts all masked to the intervention. The goal is to enrol 250 patients with a 1:1:1: allocation ratio: dextrose 5% in water placebo, caffeine 1.5 mg/kg and caffeine 3 mg/kg as a caffeine citrate infusion. The study drug will be administered intravenously during surgical closure and on the first two postoperative mornings. The primary outcome will be delirium, assessed via long-form Confusion Assessment Method. Secondary outcomes will include delirium severity, delirium duration, patient-reported outcomes and opioid consumption patterns. A substudy analysis will also be conducted with high-density electroencephalography (72-channel system) to identify neural abnormalities associated with delirium and Mild Cognitive Impairment at preoperative baseline. ETHICS AND DISSEMINATION: This study was approved by the University of Michigan Medical School Institutional Review Board (HUM00218290). An independent data and safety monitoring board has also been empanelled and has approved the clinical trial protocol and related documents. Trial methodology and results will be disseminated via clinical and scientific journals along with social and news media. TRIAL REGISTRATION NUMBER: NCT05574400.
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spelling pubmed-101864302023-05-17 Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial Vlisides, Phillip E Ragheb, Jacqueline McKinney, Amy Mentz, Graciela Runstadler, Nathan Martinez, Selena Jewell, Elizabeth Lee, UnCheol Vanini, Giancarlo Schmitt, Eva M Inouye, Sharon K Mashour, George A BMJ Open Anaesthesia INTRODUCTION: Delirium is a major public health issue for surgical patients and their families because it is associated with increased mortality, cognitive and functional decline, prolonged hospital admission and increased healthcare expenditures. Based on preliminary data, this trial tests the hypothesis that intravenous caffeine, given postoperatively, will reduce the incidence of delirium in older adults after major non-cardiac surgery. METHODS AND ANALYSIS: The CAffeine, Postoperative Delirium And CHange In Outcomes after Surgery-2 (CAPACHINOS-2) Trial is a single-centre, placebo-controlled, randomised clinical trial that will be conducted at Michigan Medicine. The trial will be quadruple-blinded, with clinicians, researchers, participants and analysts all masked to the intervention. The goal is to enrol 250 patients with a 1:1:1: allocation ratio: dextrose 5% in water placebo, caffeine 1.5 mg/kg and caffeine 3 mg/kg as a caffeine citrate infusion. The study drug will be administered intravenously during surgical closure and on the first two postoperative mornings. The primary outcome will be delirium, assessed via long-form Confusion Assessment Method. Secondary outcomes will include delirium severity, delirium duration, patient-reported outcomes and opioid consumption patterns. A substudy analysis will also be conducted with high-density electroencephalography (72-channel system) to identify neural abnormalities associated with delirium and Mild Cognitive Impairment at preoperative baseline. ETHICS AND DISSEMINATION: This study was approved by the University of Michigan Medical School Institutional Review Board (HUM00218290). An independent data and safety monitoring board has also been empanelled and has approved the clinical trial protocol and related documents. Trial methodology and results will be disseminated via clinical and scientific journals along with social and news media. TRIAL REGISTRATION NUMBER: NCT05574400. BMJ Publishing Group 2023-05-15 /pmc/articles/PMC10186430/ /pubmed/37188468 http://dx.doi.org/10.1136/bmjopen-2023-073945 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 Anaesthesia
Vlisides, Phillip E
Ragheb, Jacqueline
McKinney, Amy
Mentz, Graciela
Runstadler, Nathan
Martinez, Selena
Jewell, Elizabeth
Lee, UnCheol
Vanini, Giancarlo
Schmitt, Eva M
Inouye, Sharon K
Mashour, George A
Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title_full Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title_fullStr Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title_full_unstemmed Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title_short Caffeine, Postoperative Delirium And Change In Outcomes after Surgery (CAPACHINOS)-2: protocol for a randomised controlled trial
title_sort caffeine, postoperative delirium and change in outcomes after surgery (capachinos)-2: protocol for a randomised controlled trial
topic Anaesthesia
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10186430/
https://www.ncbi.nlm.nih.gov/pubmed/37188468
http://dx.doi.org/10.1136/bmjopen-2023-073945
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