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

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ClinicalTrials.gov Identifier: NCT03438526
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : May 14, 2019
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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 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 : September 1, 2019
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

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 ®)
Melatonin 2mg at 8 p.m. for the duration of the hypoactive delirium

Placebo Comparator: Placebo Drug: Placebo
Placebo not fabricated yet (no information composition available)
Other Name: Oral tablet or liquid




Primary Outcome Measures :
  1. Duration of hypoactive delirium [ Time Frame: From study inclusion to delirium resolution, assessed up to 5 days ]
    Duration of hypoactive delirium in the ICU in hours


Secondary Outcome Measures :
  1. Delirium-free days on ICU [ Time Frame: From study inclusion to ICU discharge, assessed up to 7 days ]
    Duration of Delirium-free days measured in days

  2. length of ICU stay [ Time Frame: From ICU admission to ICU discharge, assessed up to 10 days ]
    length of ICU stay measured in hours

  3. Length of hospital stay [ Time Frame: From hospital admission to hospital discharge, assessed up to 15 days ]
    Length of hospital stay measured in days

  4. 90-day mortality [ Time Frame: From ICU discharge alive to 90 days after study inclusion ]
    Telephone Survey 90 days after study inclusion to evaluate 90-days mortality



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:

  • Adult patients (age 55 years or older)
  • State of hypoactive delirium upon detection in the ICU (i.e., ICDSC >2).

Exclusion Criteria:

  • Known hypersensitivity to the studied substances
  • Sleep disorder not caused by hypoactive delirium
  • Age below 55 years
  • Terminal state
  • Status epilepticus or postictal states following seizures on EEG
  • Active psychosis (of non-organic origin = functional disturbances)

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 Not yet recruiting
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

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03438526     History of Changes
Other Study ID Numbers: EKNZ 2018-00161
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
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
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants