Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-22 @ 12:19 PM
Study NCT ID:
NCT00505804
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2007-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D006220', 'term': 'Haloperidol'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002090', 'term': 'Butyrophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-22', 'studyFirstSubmitDate': '2007-07-23', 'studyFirstSubmitQcDate': '2007-07-24', 'lastUpdatePostDateStruct': {'date': '2013-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time from the commencement of treatment to extubation', 'timeFrame': 'days', 'description': 'the tiem taken to extubate the patient'}], 'secondaryOutcomes': [{'measure': 'Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale)', 'timeFrame': 'hours', 'description': 'time to sedation score'}, {'measure': 'The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated)', 'timeFrame': 'During delivery of trial medication'}, {'measure': 'Average Riker score for agitation', 'timeFrame': 'During delivery of trial medication'}, {'measure': 'Average RASS score for agitation', 'timeFrame': 'During delivery of trial medication'}, {'measure': 'Need for re-intubation', 'timeFrame': 'During the same ICU admission'}, {'measure': 'Average Bergeron ICDSC score for delirium', 'timeFrame': 'During delivery of trial medication'}, {'measure': 'Duration of ICU stay', 'timeFrame': 'days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'haloperidol'], 'conditions': ['Delirium', 'Agitation', 'Ventilator Weaning', 'Respiration, Artificial', 'Intensive Care']}, 'referencesModule': {'references': [{'pmid': '19454032', 'type': 'DERIVED', 'citation': "Reade MC, O'Sullivan K, Bates S, Goldsmith D, Ainslie WR, Bellomo R. Dexmedetomidine vs. haloperidol in delirious, agitated, intubated patients: a randomised open-label trial. Crit Care. 2009;13(3):R75. doi: 10.1186/cc7890. Epub 2009 May 19."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether dexmedetomidine is a more effective medication than haloperidol in the treatment of agitation and delirium in patients receiving mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally used for this purpose.\n\nThe investigators will study only patients who have recovered from their illness to the point that, were it not for agitation and delirium, they would no longer require mechanical ventilation.\n\nThe investigators hypothesize that patients receiving dexmedetomidine will be able to discontinue mechanical ventilation earlier than those receiving haloperidol.', 'detailedDescription': 'Up to 80% of patients undergoing intensive care have delirium. Early in the ICU stay, delirium and agitation are usually prevented using analgesic and sedative drugs which essentially render the patient unconscious. This is appropriate in the context of aggressive treatment of pathophysiological instability, which often requires multiple painful procedures. However, after the underlying pathophysiological problem has resolved, patients sometimes remain delirious and agitated. This often requires ongoing heavy sedation, which in turn necessitates continued mechanical ventilation, and can worsen the (temporarily masked) delirium. Prolonged mechanical ventilation increases the risk of ventilator associated pneumonia and other life threatening complications.\n\nThe drug most commonly used to treat delirium is haloperidol, which reduces hallucinations and unstructured thought patterns, but also reduces the interaction with the environment. Haloperidol has significant side effects, including extrapyramidal reactions (in 1-10% of patients), neuroleptic malignant syndrome (in which it is the cause in 50% of cases), and prolonged QT syndrome (which can precipitate fatal arrhythmias).\n\nAn ideal sedative agent in this context would have fewer side effects, relieve agitation without causing excessive sedation, and be easily titrated. An analgesic action might allow less opioid use, also lessening delirium. Early studies in other contexts suggest dexmedetomidine has all these properties.\n\nThe investigators hypothesise that patients with ICU-associated delirium after the resolution of their underlying pathological process who receive dexmedetomidine will be able to be extubated earlier than those who receive haloperidol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible.\n\nExclusion Criteria:\n\n* Patients who could not be extubated even if delirium or agitation were corrected. This will include:\n\n * Patients receiving high dose opioid analgesia (\\>20 m/morphine/day)\n * Patients shortly to return to the operating theatre\n * Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation.\n * Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)\n* Known allergy to haloperidol or alpha2 agonists'}, 'identificationModule': {'nctId': 'NCT00505804', 'acronym': 'Dex', 'briefTitle': 'A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Austin Health'}, 'officialTitle': 'A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium', 'orgStudyIdInfo': {'id': 'H2004/02026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: haloperidol']}], 'interventions': [{'name': 'dexmedetomidine', 'type': 'DRUG', 'description': 'Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.', 'armGroupLabels': ['1']}, {'name': 'haloperidol', 'type': 'DRUG', 'description': 'Haloperidol IV loading dose of 2.5mg, followed by a continuous infusion of 0.0 to 2mg/hr for as long as deemed necessary by the treating clinician', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rinaldo Bellomo, MD FJFICM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Austin Health, University of Melbourne'}, {'name': 'Michael C Reade, MBBS FJFICM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Austin Health, University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Austin Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Alfred', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Rinaldo Bellomo', 'investigatorAffiliation': 'Austin Health'}}}}