Melatonin for Treatment of Delirium in Critically Ill Adult Patients
ConditionDelirium
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCiusss de L'Est de l'Île de Montréal
About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Melatonin
- Placebo
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ciusss de L'Est de l'Île de Montréal
Lead sponsor
Maisonneuve-Rosemont Hospital
Collaborator
Source ClinicalTrials.gov