NCT03438526 The Basel BOMP-AID Randomized Trial
| NCT ID | NCT03438526 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Hypoactive Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2022-01-03 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 190 participants in total. It began in 2022-01-03 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study: * Adult patients (aged 55 years or older) * Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0 Exclusion Criteria: Participants meeting the following criteria are excluded from the study: * 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) * Age \<55 years * Terminal state * Status epilepticus or postictal states following seizures on electroencephalogram (EEG) * Active psychosis * Substance abuse in current medical history * Dementia * Pregnancy
Contact & Investigator
Alexa Hollinger, MD
PRINCIPAL INVESTIGATOR
University Hospital, Basel, Switzerland
Frequently Asked Questions
Who can join the NCT03438526 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Hypoactive Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03438526 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03438526 currently recruiting?
Yes, NCT03438526 is actively recruiting participants. Contact the research team at alexa.hollinger@usb.ch for enrollment information.
Where is the NCT03438526 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT03438526 clinical trial?
NCT03438526 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Alexa Hollinger, MD at University Hospital, Basel, Switzerland. The trial plans to enroll 190 participants.