Influence of Dexmedetomidine or Propofol on ICU Delirium

NCT02807467 | Terminated Phase 4 DMC

• 1 other identifier: Basel ProDex Study
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration of delirium. The infusions might have to be repeated several times to achieve resolution of delirium.

Conditions

Delirium

Keywords

reduction; delirium; duration; severity

Outcome Measures

Primary Outcomes (1)

• Reduction of ICU delirium duration assessed by ICDSC checklist

  The onset of delirium will be defined as the start of the first of a minimum of two subsequent shifts with an ICDSC ≥ 4 and an SAS ≥ 5. The end of the delirium will be defined as the end of the last shift with an ICDSC ≥ 4 that precedes a minimum of two subsequent shifts with an I CDSC \< 4.

  during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine is a potent selective α-2-adrenergic receptor agonist frequently used for sedation in the ICU, also among critically ill patients. It promotes sedation, anxiolysis, and moderate analgesia with minimal respiratory depression and has been shown to reduce severity and duration of ICU delirium.

Drug: Dexmedetomidine

Propofol

ACTIVE COMPARATOR

Standard therapy for ICU delirium.

Drug: Propofol

Interventions

Dexmedetomidine DRUG

Continuous infusion of dexmedetomidine between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.

Also known as: Dexdor

Dexmedetomidine

Propofol DRUG

Continuous infusion of propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.

Also known as: Disoprivan

Propofol

Eligibility Criteria

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

You may qualify if:

• Adult patients (age 18 years or older) in a state of delirium (hyperactive ore mixed type) upon detection in the ICU (i.e., ICDSC \>3).

You may not qualify if:

• Hypersensitivity to the active substance
• Advanced heart block (grade 2 or 3) unless implanted pacemaker
• Uncontrolled hypotension
• Severe cardiac dysfunction
• Bradycardia
• Egg allergy
• Soybean/soy allergy
• Age below 18 years
• Terminal state
• Pregnancy
• Active psychosis (of non organic origin = functional disturbances)
• Status epilepticus or postictal states following seizures on EEG

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Intensive Care Units, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Hollinger A, Ledergerber K, von Felten S, Sutter R, Ruegg S, Gantner L, Zimmermann S, Blum A, Steiner LA, Marsch S, Siegemund M. Comparison of propofol and dexmedetomidine infused overnight to treat hyperactive and mixed ICU delirium: a protocol for the Basel ProDex clinical trial. BMJ Open. 2017 Jul 13;7(7):e015783. doi: 10.1136/bmjopen-2016-015783.

  PMID: 28710219 DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Alexa Hollinger, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

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: May 9, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2019
• Primary Completion: March 3, 2022
• Study Completion: February 11, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)