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Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU)

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ClinicalTrials.gov Identifier: NCT03392376
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : July 4, 2019
Sponsor:
Collaborators:
Centre for Research in Intensive Care (CRIC)
Copenhagen Trial Unit, Center for Clinical Intervention Research
Scandinavian Critical Care Trials Group
The Danish Centre of Applied Social Science (VIVE)
Information provided by (Responsible Party):
Zealand University Hospital

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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Haloperidol Injection Other: Saline (0,9%) Phase 4

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Agents Intervening Against Delirium in Intensive Care Unit (AID-ICU) A Randomized, Blinded, Placebo-controlled Trial
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Haloperidol injection

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

Other name: Serenase

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 Name: Serenase

Placebo Comparator: Normal Saline
Saline (0,9%)
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.




Primary Outcome Measures :
  1. Days alive out of the hospital within 90 days post-randomization [ Time Frame: 90 days ]
    Number of days alive and out of hospital


Secondary Outcome Measures :
  1. Number of days alive without delirium or coma in the ICU [ Time Frame: Until ICU discharge, maximum 90 days ]
    Number of days where patients are both alive and free of delirium and coma

  2. 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 [ Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days ]
    Serious adverse reactions are: Anaphylactic reactions, Agranulocytosis, Pancytopenia, Ventricular arrhythmia, Extrapyramidal symptoms, Tardive dyskinesia, Malignant Neuroleptic Syndrome, Acute hepatic failure

  3. Usage of escape medicine [ Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days ]
    Number of patients receiving escape medicine and number of days with escape medicine per patients

  4. Number of days alive without mechanical ventilation within 90 days postrandomisation [ Time Frame: Measured every day from inclusion until ICU discharge, maximum 90 days ]
    Number of days where patients are both alive and free of mechanical ventilation

  5. Mortality [ Time Frame: 1 year ]
    Landmark mortality 1 year post-randomisation

  6. Quality of life (five level) [ Time Frame: 1 year ]
    EQ-5D-5L total score 1 year post-randomisation (1-5 of each of the five domains)

  7. Quality of life (overall self assessment) [ Time Frame: 1 year ]
    EQ-Visual Analogue Scale 1 year post-randomisation (0-100)

  8. Cognitive function 1 year after randomisation at selected sites [ Time Frame: 1 year ]
    Repeated Battery for the Assesment of Neuropsychological Status score 1 year post-randomisation at selected sites (40-150)

  9. Executive function 1 year after randomisation at selected sites [ Time Frame: 1 year ]
    Trail Making Test 1 year post-randomisation at selected sites (40-150)

  10. A health economic analysis [ Time Frame: 90 days ]
    The analytic details will be based on the primary results of the trial (cost-benefit or cost-minimisation analyses)

  11. Cognitive function at admission [ Time Frame: At inclusion (within the first week) ]
    Informant Questionnaire on Cognitive Decline in the Elderly at ICU admission at selected sites (40-150)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to haloperidol
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392376


Contacts
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Contact: Lone Musaeus Poulsen, MD +4547326451 lmp@regionsjaelland.dk
Contact: Nina Christine Andersen-Ranberg, MD +4547326493 ncan@regionsjaelland.dk

Locations
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Denmark
Dept. Intensive Care, Aabenraa Hospital Recruiting
Aabenraa, Denmark, 6200
Contact: Carsten Thee, MD       carsten.thee@rsyd.dk   
Dept. of Intensive Care, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Sven-Olaf Weber, MD       s.weber@rn.dk   
Contact: Bodil Steen Rasmussen, MD, PhD       bodil.steen.rasmussen@rn.dk   
Dept. of Intensive Care 4131, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Anders Perner, MD, PhD       anders.perner@regionh.dk   
Dept. of Intensive Care, Bispebjerg Hospital Not yet recruiting
Copenhagen, Denmark, 2400
Contact: Anne Lindhart, MD       anne.lindhart.01@regionh.dk   
Dept. of Intensive Care, Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Sofie Andreasen, MD       anne.sofie.andreasen@regionh.dk   
Dept. of Intensive Care, Herning Hospital Recruiting
Herning, Denmark, 7400
Contact: Troels Bek Jensen, MD       trojense@rm.dk   
Sub-Investigator: Robert Winding, MD         
Dept. of Intensive Care, Nordsjaelland Hospital Recruiting
Hillerød, Denmark, 3400
Contact: Morten Bestle, MD, PhD       morten.bestle@regionh.dk   
Dept. of Intensive Care, Holbæk Hospital Not yet recruiting
Holbæk, Denmark, 4300
Contact: Hans Henrik Bülow, MD       hhbu@regionsjaelland.dk   
Dept. of Intensive Care, Holstebro Hospital Recruiting
Holstebro, Denmark, 7500
Contact: Nilanjan Dey, MD       nilanjan.dey@vest.rm.dk   
Dept. of Intensive Care, Zealand University Hospital, Køge Recruiting
Køge, Denmark, 4600
Contact: Nina Christine Andersen-Ranberg, MD       ncan@regionsjaelland.dk   
Sub-Investigator: Hans Christian Boesen, MD         
Sub-Investigator: Stine Estrup, MD         
Dept. of Intensive Care, Nykøbing Falster Hospital Recruiting
Nykøbing Falster, Denmark, 4800
Contact: Helle Scharling Pedersen, MD       hbpn@regionsjaelland.dk   
Dept of intensive care, Odense University Hospital Not yet recruiting
Odense, Denmark, 5000
Contact: Louise Gramstrup Nielsen, MD         
Dept. of Intensive Care, Zealand University Hospital Roskilde Recruiting
Roskilde, Denmark, 4000
Contact: Henrik Plank Pedersen, MD,       hppd@regionsjaelland.dk   
Dept. of Intensive Care, Slagelse Hospital Not yet recruiting
Slagelse, Denmark, 4200
Contact: Susanne Andi Iversen, MD       saiv@regionsjaelland.dk   
Dept. of Intensive Care, Sønderborg Hospital Recruiting
Sønderborg, Denmark, 6400
Contact: Siv Leivdal, MD       siv.leivdal@rsyd.dk   
Finland
Dept. of Intensive Care, Helsinki University Central Hospital Recruiting
Helsinki, Finland, 00120
Contact: Johanna Hästbacka, MD, PhD       johanna.hastbacka@hus.fi   
Dept of intensive care, Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Outi Inkinen, MD         
Germany
Dept of intensive care, Universitätsklinikum Schleswig-Hostein Not yet recruiting
Kiel, Germany, 24105
Contact: Matthias Kott, MD, DMSc         
Italy
Dept. of Neurosurgical Intensive Care, San Gerardo Hospital, Monza. Not yet recruiting
Monza, Italy
Contact: Giuseppe Citerio, MD, PhD       giuseppeciterio@unimib.it   
Norway
Dept. of Intensive Care, Oslo University Hospital, Rikshospitalet Not yet recruiting
Oslo, Norway, N-0424
Contact: Luis George Romundstad, MD, PhD       luisro@medisin.uio.no   
Spain
Dept. of Intensive Care, Hospital Universitari Arnau de Vilanova Not yet recruiting
Lleida, Spain, 25198
Contact: Jesus Caballero, MD       jecablo@gmail.com   
Sponsors and Collaborators
Zealand University Hospital
Centre for Research in Intensive Care (CRIC)
Copenhagen Trial Unit, Center for Clinical Intervention Research
Scandinavian Critical Care Trials Group
The Danish Centre of Applied Social Science (VIVE)
Investigators
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Study Chair: 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

Additional Information:
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03392376     History of Changes
Other Study ID Numbers: REG-169-2017
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Zealand University Hospital:
ICU Delirium
Haloperidol

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents