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The Basel BOMP-AID Randomized Trial (BOMP-AID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438526
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease Intervention/treatment Phase
Hypoactive Delirium Drug: Melatonin (Circadin ®) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Better Outcome With Melatonin Compared to Placebo Administered to Normalize Sleep-wake Cycle and Treat Hypoactive ICU Delirium The Basel BOMP-AID Randomized Trial
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: Melatonin (Circadin ®) Drug: Melatonin (Circadin ®)
4 mg of oral melatonin at 8 p.m. for the length of the duration of the hypoactive delirium

Placebo Comparator: Placebo Drug: Placebo
Lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.), mocrocristalline cellulose
Other Name: Oral tablet




Primary Outcome Measures :
  1. Duration of hypoactive delirium [ 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 days ]
    Duration of hypoactive delirium in the ICU in 8-hour shifts


Secondary Outcome Measures :
  1. Delirium-free days at 28 days after study inclusion [ Time Frame: From study inclusion to ICU discharge, assessed up to 28 days ]
    Duration of Delirium-free days measured in days

  2. Death until day 28, day 90, and day 365 from ICU admission [ Time Frame: Assessed at 28 days, 90 days, and 365 days after study inclusion ]
    Telephone Survey 28 days, 90 days and 365 days after study inclusion

  3. Number of ventilator 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 days ]
    Number of days on mechanical ventilation measured in days

  4. Length of ICU stay [ 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 days ]
    Length of ICU stay measured in hours

  5. Length of hospital stay [ Time Frame: From hospital admission to hospital discharge, assessed daily until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 90 days ]
    Length of hospital stay measured in days

  6. Sleep quality [ Time Frame: From study inclusion until study termination, assessed daily until the date of first documented progression (i.e., delirium resolution) or date of death from any cause, whichever came first, assessed up to 28 days ]
    Assessed by the Richards-Campbell Sleep Questionnaire (RCSQ; total score)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438526


Contacts
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Contact: Alexa Hollinger, MD +41786747130 alexa.hollinger@usb.ch
Contact: Martin Siegemund, MD +413286414 martin.siegemund@usb.ch

Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Contact: Alexa Hollinger, MD    0613286508    alexa.hollinger@usb.ch   
Contact: Martin Siegemund, MD    0613286414    martin.siegemund@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Alexa Hollinger, MD University Hospital, Basel, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03438526    
Other Study ID Numbers: EKNZ 2018-00161
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be communicated to patients based on expected speed-up in convalescence from delirious state. During the study ongoing and until publication there will be no access to our data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Delirium
Hypokinesia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants