Agents Intervening Against Delirium in Intensive Care Unit

NCT03392376 | Unknown Phase 4 DMC

• 1 other identifier: REG-169-2017
• Study Type: interventional
• Target: 1,000
• Locations: 4 countries
• Sites: 16

Brief 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

Keywords

ICU Delirium; Haloperidol

Outcome Measures

Primary Outcomes (3)

• Days alive out of the hospital within 90 days post-randomization

  Number of days alive and out of hospital

  90 days

• 90-day mortality

  Death from any cause within 90 days post-randomization

  90 days

• Hospital Length of Stay

  Total number of days the patient is admitted to any hospital within the 90-day intervention period

  90 days

Secondary Outcomes (11)

• Number of days alive without delirium or coma in the ICU

  Until ICU discharge, maximum 90 days

• Number of patients with one or more serious adverse reactions to haloperidol and the total number of serious adverse reactions to haloperidol compared with placebo

  Measured every day from inclusion until ICU discharge, maximum 90 days

• Usage of escape medicine

  Measured every day from inclusion until ICU discharge, maximum 90 days

• Number of days alive without mechanical ventilation within 90 days postrandomisation

  Measured every day from inclusion until ICU discharge, maximum 90 days

• Mortality

  1 year

Study Arms (2)

Haloperidol injection

EXPERIMENTAL

Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase

Drug: Haloperidol Injection

Normal Saline

PLACEBO COMPARATOR

Saline (0,9%)

Other: Saline (0,9%)

Interventions

Haloperidol Injection DRUG

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.

Also known as: Serenase

Haloperidol injection

Saline (0,9%) OTHER

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.

Normal Saline

Eligibility Criteria

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

You may qualify if:

• Acute admission to the ICU AND
• Age ≥ 18 years AND
• Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC

You may not qualify if:

• Contraindications to haloperidol
• Permanently incompetent (e.g. dementia, mental retardation)
• Delirium assessment non-applicable (coma or language barriers)
• Withdrawal from active therapy
• Fertile women (women \< 50) with positive urine human chorionic gonadotropin (hCG) or plasma hCG.
• Consent according to national regulations not obtainable
• Patients under coercive measures by regulatory authorities
• Patients with alcohol-induced delirium (Delirium Tremens)

Sponsors & Collaborators

• Zealand University Hospital: lead
• Centre for Research in Intensive Care (CRIC): collaborator
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator
• Scandinavian Critical Care Trials Group: collaborator
• The Danish Centre of Applied Social Science (VIVE): collaborator

Study Sites (16)

Dept. Intensive Care, Aabenraa Hospital

Aabenraa, 6200, Denmark

Location

Dept. of Intensive Care, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Dept. of Intensive Care, Herlev Hospital

Herlev, 2730, Denmark

Location

Dept. of Intensive Care, Herning Hospital

Herning, 7400, Denmark

Location

Dept. of Intensive Care, Nordsjaelland Hospital

Hillerød, 3400, Denmark

Location

Regionshospitalet Nordjylland, Hjørring

Hjørring, 9800, Denmark

Location

Dept. of Intensive Care, Holstebro Hospital

Holstebro, 7500, Denmark

Location

Dept. of Intensive Care, Zealand University Hospital, Køge

Køge, 4600, Denmark

Location

Dept. of Intensive Care, Nykøbing Falster Hospital

Nykøbing Falster, 4800, Denmark

Location

Dept of intensive care, Odense University Hospital

Odense, 5000, Denmark

Location

Dept. of Intensive Care, Zealand University Hospital Roskilde

Roskilde, 4000, Denmark

Location

Dept. of Intensive Care, Sønderborg Hospital

Sønderborg, 6400, Denmark

Location

Dept. of Intensive Care, Helsinki University Central Hospital

Helsinki, 00120, Finland

Location

Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.

Monza, Italy

Location

UHW Adult Critical Care Cardiff

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (2)

• Mortensen CB, Andersen-Ranberg NC, Poulsen LM, Granholm A, Rasmussen BS, Kjaer MN, Lange T, Ebdrup BH, Collet MO, Andreasen AS, Bestle MH, Uslu B, Pedersen HS, Nielsen LG, Hastbacka J, Jensen TB, Damgaard K, Sommer T, Morgen M, Dey N, Citerio G, Estrup S, Egerod I, Samuelson K, Perner A, Mathiesen O. Long-term outcomes with haloperidol versus placebo in acutely admitted adult ICU patients with delirium. Intensive Care Med. 2024 Jan;50(1):103-113. doi: 10.1007/s00134-023-07282-7. Epub 2024 Jan 3.

  PMID: 38170227 DERIVED

• Andersen-Ranberg NC, Poulsen LM, Perner A, Wetterslev J, Estrup S, Hastbacka J, Morgan M, Citerio G, Caballero J, Lange T, Kjaer MN, Ebdrup BH, Engstrom J, Olsen MH, Oxenboll Collet M, Mortensen CB, Weber SO, Andreasen AS, Bestle MH, Uslu B, Scharling Pedersen H, Gramstrup Nielsen L, Toft Boesen HC, Jensen JV, Nebrich L, La Cour K, Laigaard J, Haurum C, Olesen MW, Overgaard-Steensen C, Westergaard B, Brand B, Kingo Vesterlund G, Thornberg Kyhnauv P, Mikkelsen VS, Hyttel-Sorensen S, de Haas I, Aagaard SR, Nielsen LO, Eriksen AS, Rasmussen BS, Brix H, Hildebrandt T, Schonemann-Lund M, Fjeldsoe-Nielsen H, Kuivalainen AM, Mathiesen O; AID-ICU Trial Group. Haloperidol for the Treatment of Delirium in ICU Patients. N Engl J Med. 2022 Dec 29;387(26):2425-2435. doi: 10.1056/NEJMoa2211868. Epub 2022 Oct 26.

  PMID: 36286254 DERIVED

Related Links

• LINK to the AID-ICU webpage

MeSH Terms

Conditions

Delirium

Interventions

Haloperidol; Sodium Chloride

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)

Butyrophenones; Ketones; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• OIe Mathiesen, MD, PhD

  Zealand University Hospital

  STUDY CHAIR

• Anders Perner, MD,PhD

  Rigshospitalet, Denmark

  STUDY CHAIR

• Jørn Wetterslev, MD, PhD

  Copenhagen Trial Unit, Center for Clinical Intervention Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 30, 2017
• First Posted: January 8, 2018
• Study Start: June 13, 2018
• Primary Completion: July 9, 2022
• Study Completion: July 1, 2023
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

GB (1); FI (1); DK (13); IT (1)