Agents Intervening Against Delirium in Intensive Care Unit
NCT ID: NCT03392376
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1000 participants
INTERVENTIONAL
2018-06-13
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Haloperidol injection
Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily.
Other name: Serenase
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.
Normal Saline
Saline (0,9%)
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years AND
* Diagnosed delirium with validated screening Tool as either CAM-ICU or ICDSC
Exclusion Criteria
* Habitual treatment with any antipsychotic medication or treatment with antipsychotics in the ICU prior to inclusion
* 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)
18 Years
ALL
No
Sponsors
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Centre for Research in Intensive Care (CRIC)
OTHER
Copenhagen Trial Unit, Center for Clinical Intervention Research
OTHER
Scandinavian Critical Care Trials Group
OTHER
The Danish Centre of Applied Social Science (VIVE)
UNKNOWN
Zealand University Hospital
OTHER
Responsible Party
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Principal Investigators
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OIe Mathiesen, MD, PhD
Role: STUDY_CHAIR
Zealand University Hospital
Anders Perner, MD,PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Jørn Wetterslev, MD, PhD
Role: STUDY_CHAIR
Copenhagen Trial Unit, Center for Clinical Intervention Research
Locations
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Dept. Intensive Care, Aabenraa Hospital
Aabenraa, , Denmark
Dept. of Intensive Care, Aalborg University Hospital
Aalborg, , Denmark
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Dept. of Intensive Care, Herlev Hospital
Herlev, , Denmark
Dept. of Intensive Care, Herning Hospital
Herning, , Denmark
Dept. of Intensive Care, Nordsjaelland Hospital
Hillerød, , Denmark
Regionshospitalet Nordjylland, Hjørring
Hjørring, , Denmark
Dept. of Intensive Care, Holstebro Hospital
Holstebro, , Denmark
Dept. of Intensive Care, Zealand University Hospital, Køge
Køge, , Denmark
Dept. of Intensive Care, Nykøbing Falster Hospital
Nykøbing Falster, , Denmark
Dept of intensive care, Odense University Hospital
Odense, , Denmark
Dept. of Intensive Care, Zealand University Hospital Roskilde
Roskilde, , Denmark
Dept. of Intensive Care, Sønderborg Hospital
Sønderborg, , Denmark
Dept. of Intensive Care, Helsinki University Central Hospital
Helsinki, , Finland
Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza.
Monza, , Italy
UHW Adult Critical Care Cardiff
Cardiff, , United Kingdom
Countries
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References
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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.
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.
Related Links
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LINK to the AID-ICU webpage
Other Identifiers
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REG-169-2017
Identifier Type: -
Identifier Source: org_study_id
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