Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study
Introduction Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID (Better Outcome with Melatonin compared to Placebo Administered to normalize...
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BMJ Publishing Group
2020-04-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/4/e034873.full |
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| author | Alexa Hollinger Stefanie von Felten Raoul Sutter Jan Huber Fabian Tran Simona Reinhold Salim Abdelhamid Atanas Todorov Caroline Eva Gebhard Christian Cajochen Luzius A Steiner Martin Siegemund |
| author_facet | Alexa Hollinger Stefanie von Felten Raoul Sutter Jan Huber Fabian Tran Simona Reinhold Salim Abdelhamid Atanas Todorov Caroline Eva Gebhard Christian Cajochen Luzius A Steiner Martin Siegemund |
| author_sort | Alexa Hollinger |
| collection | DOAJ |
| description | Introduction Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID (Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium) randomised trial targets improvement of hypoactive delirium therapy in critically ill patients and will be conducted as a counterpart to the Basel ProDex Study (Study Protocol, BMJ Open, July 2017) on hyperactive and mixed delirium. The aim of the BOMP-AID trial is to assess the superiority of melatonin to placebo for the treatment of hypoactive delirium in the ICU. The study hypothesis is based on the assumption that melatonin administered at night restores a normal circadian rhythm, and that restoration of a normal circadian rhythm will cure delirium.Methods and analysis The Basel BOMP-AID study is an investigator-initiated, single-centre, randomised controlled clinical trial for the treatment of hypoactive delirium with the once daily oral administration of melatonin 4 mg versus placebo in 190 critically ill patients. The primary outcome measure is delirium duration in 8-hour shifts. Secondary outcome measures include delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality. Patients will be followed after 3 and 12 months for activities of daily living and mortality assessment. Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium. Results will be presented using an intention-to-treat approach.Ethics and dissemination This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use; Good Clinical Practice (GCP) or ISO EN 14155 (as far as applicable), as well as all national legal and regulatory requirements. Study results will be presented in international conferences and published in a peer-reviewed journal.Trial registration number NCT03438526.Protocol version Clinical Study Protocol Version 3, 10.03.2019. |
| format | Article |
| id | doaj-art-cf4dc1f9af9146a9b56efb4bcba7c113 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-04-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-cf4dc1f9af9146a9b56efb4bcba7c1132024-12-04T05:45:09ZengBMJ Publishing GroupBMJ Open2044-60552020-04-0110410.1136/bmjopen-2019-034873Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID studyAlexa Hollinger0Stefanie von Felten1Raoul Sutter2Jan Huber3Fabian Tran4Simona Reinhold5Salim Abdelhamid6Atanas Todorov7Caroline Eva Gebhard8Christian Cajochen9Luzius A Steiner10Martin Siegemund11Department of Clinical Research, University of Basel, Basel, SwitzerlandDepartment of Clinical Research, Clinical Trial Unit, c/o University Hospital Basel, University of Basel, Basel, SwitzerlandDepartment of Neurology, University Hospital Basel, Basel, SwitzerlandIntensive Care Unit, University Hospital Basel, Basel, SwitzerlandIntensive Care Unit, University Hospital Basel, Basel, SwitzerlandIntensive Care Unit, University Hospital Basel, Basel, SwitzerlandInternal Medicine, Kantonsspital Baden AG, Baden, SwitzerlandIntensive Care Unit, University Hospital Basel, Basel, SwitzerlandIntensive Care Unit, University Hospital Basel, Basel, SwitzerlandFaculty of Medicine, University of Basel, Basel, BS, SwitzerlandFaculty of Medicine, University of Basel, Basel, BS, SwitzerlandIntensive Care Unit, Department of Acute Medicine, University Hospital Basel, Basel, SwitzerlandIntroduction Delirium is frequently observed in the intensive care unit (ICU) population, in particular. Until today, there is no evidence for any reliable pharmacological intervention to treat delirium. The Basel BOMP-AID (Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium) randomised trial targets improvement of hypoactive delirium therapy in critically ill patients and will be conducted as a counterpart to the Basel ProDex Study (Study Protocol, BMJ Open, July 2017) on hyperactive and mixed delirium. The aim of the BOMP-AID trial is to assess the superiority of melatonin to placebo for the treatment of hypoactive delirium in the ICU. The study hypothesis is based on the assumption that melatonin administered at night restores a normal circadian rhythm, and that restoration of a normal circadian rhythm will cure delirium.Methods and analysis The Basel BOMP-AID study is an investigator-initiated, single-centre, randomised controlled clinical trial for the treatment of hypoactive delirium with the once daily oral administration of melatonin 4 mg versus placebo in 190 critically ill patients. The primary outcome measure is delirium duration in 8-hour shifts. Secondary outcome measures include delirium-free days and death at 28 days after study inclusion, number of ventilator days, length of ICU and hospital stay, and sleep quality. Patients will be followed after 3 and 12 months for activities of daily living and mortality assessment. Sample size was calculated to demonstrate superiority of melatonin compared with placebo regarding the duration of delirium. Results will be presented using an intention-to-treat approach.Ethics and dissemination This study has been approved by the Ethics Committee of Northwestern and Central Switzerland and will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use; Good Clinical Practice (GCP) or ISO EN 14155 (as far as applicable), as well as all national legal and regulatory requirements. Study results will be presented in international conferences and published in a peer-reviewed journal.Trial registration number NCT03438526.Protocol version Clinical Study Protocol Version 3, 10.03.2019.https://bmjopen.bmj.com/content/10/4/e034873.full |
| spellingShingle | Alexa Hollinger Stefanie von Felten Raoul Sutter Jan Huber Fabian Tran Simona Reinhold Salim Abdelhamid Atanas Todorov Caroline Eva Gebhard Christian Cajochen Luzius A Steiner Martin Siegemund Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study BMJ Open |
| title | Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study |
| title_full | Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study |
| title_fullStr | Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study |
| title_full_unstemmed | Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study |
| title_short | Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep–wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study |
| title_sort | study protocol for a prospective randomised double blind placebo controlled clinical trial investigating a better outcome with melatonin compared to placebo administered to normalize sleep wake cycle and treat hypoactive icu delirium the basel bomp aid study |
| url | https://bmjopen.bmj.com/content/10/4/e034873.full |
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