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| Name | Class |
|---|---|
| Centre for Research in Intensive Care (CRIC) | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research | OTHER |
| Scandinavian Critical Care Trials Group | OTHER |
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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.
Delirium among critically ill patients in the intensive care unit (ICU) is a common condition associated with increased morbidity and mortality. No evidence-based treatment exist of this condition. Haloperidol is the most frequently used agent to treat ICU-related delirium, but according to the available literature there is no firm evidence of efficacy and safety of this intervention. AID-ICU aims to assess the benefits and harms of haloperidol in adult, critically ill patients with delirium in the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haloperidol injection | Experimental | Haloperidol 2,5mg x 3 daily, with additional as needed doses to a maximum of 20mg/daily. Other name: Serenase |
|
| Normal Saline | Placebo Comparator | Saline (0,9%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of days alive without delirium or coma in the ICU | Number of days where patients are both alive and free of delirium and coma | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Intensive Care, Aabenraa Hospital | Aabenraa | 6200 | Denmark | |||
| Dept. of Intensive Care, Aalborg University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38170227 | Derived | 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. | |
| 36286254 |
| Label | URL |
|---|---|
| LINK to the AID-ICU webpage | View source |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006220 | Haloperidol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
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| The Danish Centre of Applied Social Science (VIVE) |
| UNKNOWN |
Parallel Assignment
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|
| 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. |
|
Serious adverse reactions are: Anaphylactic reactions, Agranulocytosis, Pancytopenia, Ventricular arrhythmia, Extrapyramidal symptoms, Tardive dyskinesia, Malignant Neuroleptic Syndrome, Acute hepatic failure |
| Measured every day from inclusion until ICU discharge, maximum 90 days |
| Usage of escape medicine | Number of patients receiving escape medicine and number of days with escape medicine per patients | Measured every day from inclusion until ICU discharge, maximum 90 days |
| Number of days alive without mechanical ventilation within 90 days postrandomisation | Number of days where patients are both alive and free of mechanical ventilation | Measured every day from inclusion until ICU discharge, maximum 90 days |
| Mortality | Landmark mortality 1 year post-randomisation | 1 year |
| Quality of life (five level) | EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains) | 1 year |
| Quality of life (overall self assessment) | EQ-Visual Analogue Scale 1 year post-randomisation (0-100) | 1 year |
| Cognitive function 1 year after randomisation at selected sites | Repeated Battery for the Assesment of Neuropsychological Status score 1 year post-randomisation at selected sites (40-150) | 1 year |
| Executive function 1 year after randomisation at selected sites | Trail Making Test 1 year post-randomisation at selected sites (40-150) | 1 year |
| A health economic analysis | The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses) | 90 days |
| Cognitive function at admission | Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150) | At inclusion (within the first week) |
| Aalborg |
| 9000 |
| Denmark |
| Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet | Copenhagen | 2100 | Denmark |
| Dept. of Intensive Care, Herlev Hospital | Herlev | 2730 | Denmark |
| Dept. of Intensive Care, Herning Hospital | Herning | 7400 | Denmark |
| Dept. of Intensive Care, Nordsjaelland Hospital | Hillerød | 3400 | Denmark |
| Regionshospitalet Nordjylland, Hjørring | Hjørring | 9800 | Denmark |
| Dept. of Intensive Care, Holstebro Hospital | Holstebro | 7500 | Denmark |
| Dept. of Intensive Care, Zealand University Hospital, Køge | Køge | 4600 | Denmark |
| Dept. of Intensive Care, Nykøbing Falster Hospital | Nykøbing Falster | 4800 | Denmark |
| Dept of intensive care, Odense University Hospital | Odense | 5000 | Denmark |
| Dept. of Intensive Care, Zealand University Hospital Roskilde | Roskilde | 4000 | Denmark |
| Dept. of Intensive Care, Sønderborg Hospital | Sønderborg | 6400 | Denmark |
| Dept. of Intensive Care, Helsinki University Central Hospital | Helsinki | 00120 | Finland |
| Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza. | Monza | Italy |
| UHW Adult Critical Care Cardiff | Cardiff | CF14 4XW | United Kingdom |
| 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |