Agents Intervening Against Delirium in Intensive Care Unit

Summary

Delirium is a frequent condition in the Intensive Care Unit (ICU) with no existing evidence-based treatment. The aim of the AID-ICU study is to assess the benefits and harms of haloperidol treatment for the management of ICU acquired delirium.

Conditions

• Delirium

Interventions

DRUG

Haloperidol Injection

ICU patients with diagnosed delirium are treated with 2,5mg haloperidol x 3 daily intravenously with additional as needed doses to a maximum of 20mg/daily.

OTHER

Saline (0,9%)

ICU patients with diagnosed delirium are treated with 0,5ml isotonic saline x 3 daily and as needed doses to a maximum of 4ml/daily, corresponding to the algorithm in the experimental arm.

Sponsors & Collaborators

• Centre for Research in Intensive Care (CRIC)

  collaborator OTHER

• Copenhagen Trial Unit, Center for Clinical Intervention Research

  collaborator OTHER

• Scandinavian Critical Care Trials Group

  collaborator OTHER

• The Danish Centre of Applied Social Science (VIVE)

  collaborator UNKNOWN

• Zealand University Hospital

  lead OTHER

Principal Investigators

• OIe Mathiesen, MD, PhD · Zealand University Hospital

• Anders Perner, MD,PhD · Rigshospitalet, Denmark

• Jørn Wetterslev, MD, PhD · Copenhagen Trial Unit, Center for Clinical Intervention Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-13

Primary Completion

2022-07-09

Completion

2023-07-31

Countries

• Denmark
• Finland
• Italy
• United Kingdom

Study Locations