The Basel BOMP-AID Randomized Trial

NCT03438526 | Recruiting Phase 4

• 1 other identifier: EKNZ 2018-00161
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoactive Delirium

Outcome Measures

Primary Outcomes (1)

• Duration of hypoactive delirium

  Duration of hypoactive delirium in the ICU in 8-hour shifts

  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

Secondary Outcomes (6)

• Delirium-free days at 28 days after study inclusion

  From study inclusion to ICU discharge, assessed up to 28 days

• Death until day 28, day 90, and day 365 from ICU admission

  Assessed at 28 days, 90 days, and 365 days after study inclusion

• Number of ventilator days

  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

• Length of ICU stay

  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 hospital stay

  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

Study Arms (2)

Melatonin (Circadin ®)

EXPERIMENTAL

Drug: Melatonin (Circadin ®)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Melatonin (Circadin ®) DRUG

4 mg of oral melatonin at 8 p.m. for the length of the duration of the hypoactive delirium

Melatonin (Circadin ®)

Placebo DRUG

Lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.), mocrocristalline cellulose

Also known as: Oral tablet

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (aged 55 years or older)
• Current delirium (hypoactive type) detected by a specialised assessment method: ICDSC score \>2 and RASS score \< 0

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (1)

• Hollinger A, von Felten S, Sutter R, Huber J, Tran F, Reinhold S, Abdelhamid S, Todorov A, Gebhard CE, Cajochen C, Steiner LA, Siegemund M. Study protocol for a prospective randomised double-blind placebo-controlled clinical trial investigating a Better Outcome with Melatonin compared to Placebo Administered to normalize sleep-wake cycle and treat hypoactive ICU Delirium: the Basel BOMP-AID study. BMJ Open. 2020 Apr 30;10(4):e034873. doi: 10.1136/bmjopen-2019-034873.

  PMID: 32354780 DERIVED

MeSH Terms

Interventions

Melatonin; Tablets

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Alexa Hollinger, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa Hollinger, MD

CONTACT

+41786747130; alexa.hollinger@usb.ch

Martin Siegemund, MD

CONTACT

+413286414; martin.siegemund@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 19, 2018
• Study Start: January 3, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)