Clinical trial
DELIRE-ICU: A Randomised Controlled Feasibility Trial of Melatonin vs Placebo in the Treatment of Delirium in the Intensive Care Unit
Name
2023-3247
Description
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.
Trial arms
Trial start
2023-02-01
Estimated PCD
2024-09-30
Trial end
2024-11-30
Status
Recruiting
Phase
Early phase I
Treatment
Melatonin
Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.
Arms:
Enteral melatonin 9 mg
Placebo
Study drug will be given at 21:00 daily, starting on the day of enrolment until delirium resolution, hospital discharge, death, or up to 14 days. The study medication will be given by mouth (PO or per os) or, if needed, via the feeding tube.
Arms:
Enteral placebo
Size
30
Primary endpoint
Feasibility: Enrollment rate
8 months
Clinical: Duration of delirium
14 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'All study personnel, care provider, patients and their families will remain blinded. Randomization will be performed by members of the Pharmacy Research Department.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-02-07
1 organization
1 product
1 drug
1 indication
Organization
CIUSSS de l'Est de l'Île de MontréalProduct
MelatoninIndication
DeliriumDrug
Varlilumab