Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05713877
Other study ID # 2023-3247
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 1, 2023
Est. completion date November 30, 2024

Study information

Verified date February 2024
Source Ciusss de L'Est de l'Île de Montréal
Contact Johannie Beaucage-Charron, Pharm.D., M.Sc.
Phone 514 252 3400
Email johannie.beaucage-charron.cemtl@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The prevalence of delirium is high in the intensive care unit (ICU), yet there is no pharmacological treatment that has been proven effective. The investigators hypothesize that melatonin, given on a daily basis at 21:00, will safely decrease the mean duration of a delirium episode in ICU patients. The current literature evaluating melatonin as a treatment for delirium is lacking, therefore more studies are needed. It is estimated that an alteration of sleep pattern can be found in up to 75% of patients with delirium. This raises the hypothesis that prevention and treatment of sleep disorders could potentially improve delirium. Sleep and circadian rhythm disturbances are associated with low endogenous melatonin secretion and studies have shown that it also occurs in patients with delirium. Thus, the objective is to conduct a phase II double blind, placebo-controlled randomized trial comparing melatonin 9 mg to placebo to evaluate the feasibility of a future large-scale RCT. Participants will be followed during their stay in the ICU and after their transfer on another unit up to a maximum of 14 days. Feasibility of the larger trial will mainly be based on enrollment rates.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date November 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
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.

Locations

Country Name City State
Canada Hopital Maisonneuve-Rosemont Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Ciusss de L'Est de l'Île de Montréal Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (8)

Burry L, Scales D, Williamson D, Foster J, Mehta S, Guenette M, Fan E, Detsky M, Azad A, Bernard F, Rose L. Feasibility of melatonin for prevention of delirium in critically ill patients: a protocol for a multicentre, randomised, placebo-controlled study. BMJ Open. 2017 Mar 30;7(3):e015420. doi: 10.1136/bmjopen-2016-015420. — View Citation

Farasat S, Dorsch JJ, Pearce AK, Moore AA, Martin JL, Malhotra A, Kamdar BB. Sleep and Delirium in Older Adults. Curr Sleep Med Rep. 2020;6(3):136-148. doi: 10.1007/s40675-020-00174-y. Epub 2020 Jul 27. — View Citation

Flacker JM, Lipsitz LA. Neural mechanisms of delirium: current hypotheses and evolving concepts. J Gerontol A Biol Sci Med Sci. 1999 Jun;54(6):B239-46. doi: 10.1093/gerona/54.6.b239. Erratum In: J Gerontol A Biol Sci Med Sci 1999 Jul;54(7):B275. — View Citation

Pandharipande PP, Morandi A, Adams JR, Girard TD, Thompson JL, Shintani AK, Ely EW. Plasma tryptophan and tyrosine levels are independent risk factors for delirium in critically ill patients. Intensive Care Med. 2009 Nov;35(11):1886-92. doi: 10.1007/s00134-009-1573-6. Epub 2009 Jul 9. — View Citation

Stollings JL, Kotfis K, Chanques G, Pun BT, Pandharipande PP, Ely EW. Delirium in critical illness: clinical manifestations, outcomes, and management. Intensive Care Med. 2021 Oct;47(10):1089-1103. doi: 10.1007/s00134-021-06503-1. Epub 2021 Aug 16. — View Citation

Sun T, Sun Y, Huang X, Liu J, Yang J, Zhang K, Kong G, Han F, Hao D, Wang X. Sleep and circadian rhythm disturbances in intensive care unit (ICU)-acquired delirium: a case-control study. J Int Med Res. 2021 Mar;49(3):300060521990502. doi: 10.1177/0300060521990502. — View Citation

Thabane L, Ma J, Chu R, Cheng J, Ismaila A, Rios LP, Robson R, Thabane M, Giangregorio L, Goldsmith CH. A tutorial on pilot studies: the what, why and how. BMC Med Res Methodol. 2010 Jan 6;10:1. doi: 10.1186/1471-2288-10-1. Erratum In: BMC Med Res Methodol. 2023 Mar 11;23(1):59. — View Citation

Weinhouse GL, Schwab RJ, Watson PL, Patil N, Vaccaro B, Pandharipande P, Ely EW. Bench-to-bedside review: delirium in ICU patients - importance of sleep deprivation. Crit Care. 2009;13(6):234. doi: 10.1186/cc8131. Epub 2009 Dec 7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Feasibility: Completion of study Proportion of participants who completed the study and reasons associated with withdrawal. 8 months
Other Feasibility: MDAS assessment time (minutes) Time required for the administration of the Memorial Delirium Assessment Scale (MDAS).
Values from 0 to 30. A higher score means a worse outcome.
8 months
Other Feasibility: Completion of ICDSC Proportion of missing data in the completion of the Intensive Care Delirium Screening Checklist (ICDSC).
Values from 0 to 8. A higher score means a worse outcome.
8 months
Other Clinical: Antipsychotics dose (mg) administered to participants Cumulative dose of de novo antipsychotics, reported in haloperidol equivalent dose, received by participants during delirium. 14 days
Primary Feasibility: Enrollment rate Average enrollment rate of participants per month. 8 months
Primary Clinical: Duration of delirium Compare the average duration of an episode of delirium defined as the number of days with ICDSC score =4 between the 2 groups. 14 days
Secondary Feasibility: Study adherence Proportion of administered doses in the prescribed dose administration window (between 19:00 and 23:00 hours) divided by total number of eligible study days. 8 months
Secondary Feasibility: Consent rate Proportion of participants recruited among eligible patients. 8 months
Secondary Clinical: Adverse events Incidence of adverse events reported in the Canadian melatonin monograph (i.e. headache and nausea) observed by the investigators or reported by the treating team. 14 days
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT05891873 - Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT06194474 - Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
Completed NCT03095417 - Improving the Recovery and Outcome Every Day After the ICU N/A
Completed NCT05395559 - Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Not yet recruiting NCT04846023 - Pediatric Delirium Screening in the PICU Via EEG N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Withdrawn NCT02673450 - PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
Recruiting NCT03256500 - Transcranial Direct Current Stimulation for the Treatment of Delirium N/A
Not yet recruiting NCT02892968 - ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Recruiting NCT03165539 - Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
Completed NCT02554253 - The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction Phase 2
Completed NCT02518646 - DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models N/A
Recruiting NCT02305589 - The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium N/A
Completed NCT02628925 - Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale N/A