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The Basel BOMP-AID Randomized Trial

RecruitingPhase 4Ages 55 Years - anyAllUniversity Hospital, Basel, Switzerland
NCT03438526 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population. This long-term experience with delirium suggests a high socioeconomic liability and has been a focus of many studies. The aforementioned consequences of delirium are observed in all of three subtypes: hypoactive, hyperactive, and mixed. Pharmacological treatment options for hypoactive delirium are

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📋 Eligibility rules (as published)
Inclusion Criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study: * Adult patients (aged 55 years or older) * Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0 Exclusion Criteria: Participants meeting the following criteria are excluded from the study: * Delirium prior to ICU admission * Sleep disorder not caused by hypoactive delirium * Sedation in the ICU * Hypersensitivity to the studied substances (i.e., melatonin, placebo content) * Age \<55 years * Terminal state * Status epilepticus or postictal states following seizures on electroencephalogram (EEG) * Active psychosis * Substance abuse in current medical history * Dementia * Pregnancy
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What it tests

  • Melatonin (Circadin ®)
  • Placebo
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Where

1 site
University Hospital Basel
Basel, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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