Better Outcome With Melatonin Compared to Placebo Administered to Normalize Sleep-wake Cycle and Treat Hypoactive ICU Delirium The Basel BOMP-AID Randomized Trial

Who is this study for? Patients with hypoactive ICU delirium
What treatments are being studied? Melatonin
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Alexa Hollinger, MD
alexa.hollinger@usb.ch
+41786747130
Backup
Martin Siegemund, MD
martin.siegemund@usb.ch
+413286414
Time Frame
Start Date: 2022-01-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 190
Treatments
Experimental: Melatonin (Circadin ®)
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov