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Melatonin for Treatment of Delirium in Critically Ill Adult Patients

RecruitingPhase 2Ages 18 Years - anyAllCiusss de L'Est de l'Île de Montréal
NCT05713877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to determine the feasibility of conducting a randomized controlled trial (RCT) with melatonin for treatment of delirium in critically ill adult patients. From a feasibility perspective, the investigators believe that the proposed design will achieve the minimum enrollment rate necessary to conduct a future RCT on a larger scale.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18 years or older admitted to the intensive care unit; * Anticipated ICU stay \> 48 hours; * ICDSC score greater than or equal to 4 for a maximum of 48 hours prior to randomization. Exclusion Criteria: * Known allergy or hypersensitivity to melatonin or to ingredients in ORA-BLEND SF®; * Use of melatonin within 24 hours prior to randomization; * Presence of severe structural brain injury (intracranial hemorrhage or traumatic brain injury), severe major neurocognitive disorder, advanced neurodegenerative disease or hepatic encephalopathy; * Diagnosis of schizophrenia, bipolar affective disorder, psychotic depression, uremic encephalopathy or alcohol withdrawal; * Presence of active seizures, coma, aphasia or severe intellectual disability; * Limited short-term vital prognosis; * Diagnosis of delirium prior to ICU admission; * Pregnancy or breastfeeding; * Absolute contraindication to receive enteral medication; * Inability to understand or speak English or French; * Total blindness.
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What it tests

  • Melatonin
  • Placebo
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Where

1 site
Hopital Maisonneuve-Rosemont
Montreal, Canada
🤝 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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