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NCT05713877
Melatonin for Treatment of Delirium in Critically Ill Adult Patients
Conditions: Delirium
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 30
Sponsor: Ciusss de L'Est de l'Île de Montréal
Location: Canada
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05713877). StuddyBuddy aggregates publicly available trial information.