The Basel BOMP-AID Randomized Trial
ConditionHypoactive Delirium
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
Delirium is a neurobehavioural syndrome that frequently develops in the postoperative and/or ICU setting. The incidence of elderly patients who develop delirium during hospital stay ranges from 11-82%. Delirium was first described more than half a century ago in the cardiac surgery population, where it was already discovered as a state that might be accompanied by serious complications such as prolonged ICU and hospital stay, reduced quality of life and increased mortality. Furthermore, the duration of delirium is associated with worse long-term cognitive function in the general ICU population. This long-term experience with delirium suggests a high socioeconomic liability and has been a focus of many studies. The aforementioned consequences of delirium are observed in all of three subtypes: hypoactive, hyperactive, and mixed. Pharmacological treatment options for hypoactive delirium are lacking. Since patients in hypoactive delirium suffer from disturbed circadian rhythm, the investigators suggest that the administration of melatonin as a promising possibility in these patients to shorten delirium duration and to lower its severity. Previous investigations confirmed loss of melatonin rhythm in patients that had developed delirium thus reasoning the study hypothesis.
In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by the administration of melatonin compared to placebo after diagnosis of hypoactive delirium, decreases the duration of delirium and reduces the transmission to a form of agitated delirium. The administration might have to be repeated several times to achieve resolution of delirium.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (aged 55 years or older)
Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score >2 and RASS score < 0
Disqualifiers
Delirium prior to ICU admission
Sleep disorder not caused by hypoactive delirium
Sedation in the ICU
Hypersensitivity to the studied substances (i.e., melatonin, placebo content)
Trial design
Design model
Parallel
Treatments tested in this trial
Melatonin (Circadin ®)
Drug4 mg of oral melatonin at 8 p.m. for the length of the duration of the hypoactive delirium
Placebo
DrugLactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.), mocrocristalline cellulose
Treatment groups
190 Participants
are divided into 2 treatment groupsGroup A: Melatonin (Circadin ®)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Duration of hypoactive delirium
Duration of hypoactive delirium in the ICU in 8-hour shifts
Time frame
From study inclusion to delirium resolution, assessed daily until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 28 daysSecondary outcomes
1
Delirium-free days at 28 days after study inclusion
Duration of Delirium-free days measured in days
Time frame
From study inclusion to ICU discharge, assessed up to 28 days2
Death until day 28, day 90, and day 365 from ICU admission
Telephone Survey 28 days, 90 days and 365 days after study inclusion
Time frame
Assessed at 28 days, 90 days, and 365 days after study inclusion3
Number of ventilator days
Number of days on mechanical ventilation measured in days
Time frame
From study inclusion until ICU discharge, assessed daily until the date of withdrawal of mechanical ventilation or date of death from any cause, whichever came first, assessed up to 28 days4
Length of ICU stay
Length of ICU stay measured in hours
Time frame
From ICU admission to ICU discharge, assessed daily until the date of ICU discharge or date of death from any cause, whichever came first, assessed up to 28 daysSponsors and contacts
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Source ClinicalTrials.gov