Delirium Clinical Trial
— HARPOONOfficial title:
Early Pharmacological Intervention to Prevent Delirium: Haloperidol Prophylaxis in Older Emergency Department Patients
The investigators propose a multicenter, randomized, double-blinded, placebo-controlled
trial to study the effect of additive low-dose haloperidol prophylaxis on top of exciting
care in a general population of older patients (age 70 years and over) acutely admitted to
the hospital through the emergency department (ED) for general medicine and surgical
specialties, and who are at-risk for developing in-hospital delirium on admission according
to the VMS delirium risk questions (one or more positive answers out of three questions).
The investigators hypothesize that this intervention will reduce the incidence of
in-hospital delirium as well as duration and severity of delirium.
Status | Completed |
Enrollment | 242 |
Est. completion date | October 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
Inclusion Criteria: - Patients aged 70 years or over; - The patient is at increased risk for developing in-hospital delirium on admission according to one or more positive answers on the VMS delirium-risk questions; - The patient and/or proxy is able to provide written informed consent; - The patient and/or proxy speaks either Dutch or English; - The patient is admitted to the hospital for a general medicine or surgical specialty. Exclusion Criteria: - Patients presenting in the ED with delirium according to the DSM-IV criteria; - Patients with clinically significant (cardiac) disorders: QTc interval prolongation (QTc =500ms), recent acute myocardial infarction, uncompensated heart failure (working diagnosis), acute coronary syndrome (ACS), arrhythmias treated with class IA and III antiarrhythmic medicinal products, history of ventricular arrhythmia, history of torsades, clinically significant bradycardia, second or third degree heart block, uncorrected hypokalaemia (potassium level 3.0 or lower); - Patients with vascular dementia; - Patients with Lewy Body dementia; - Patients with Parkinson dementia; - Patients with (a history of) hypokinetic movement disorders; - Patients with (a history of) malignant neuroleptic syndrome; - Patients with (a history of) serotonergic syndrome; - Patients with (a history of) central anticholinergic syndrome; - Patients who will be admitted to the oncology ward; - Patients previously enrolled in the HARPOON study, or in other medical- or drug studies; - Patients using QT prolonging drugs and/or medications of which concomitant use with haloperidol is contraindicated (clinically relevant drug interactions, 1st degree, listed in the appendix of the study protocol); - Epilepsy; - Substance abuse and dependence (DSM-IV criteria) - Patients who are not able to take the study medication according to protocol (amendment) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Netherlands | Medical Center Alkmaar | Alkmaar | |
Netherlands | VUmc | Amsterdam | Noord-Holland |
Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | Brabant |
Netherlands | Spaarne Ziekenhuis | Hoofddorp | Noord Holland |
Netherlands | Rijnland Ziekenhuis | Leiderdorp | |
Netherlands | Isala Klinieken | Zwolle |
Lead Sponsor | Collaborator |
---|---|
VU University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The initial day and number of days there is a significant change from baseline in the mean Delirium Observation Screening (DOS) score, and/or delirium is diagnosed according to the DSM-IV criteria. | Reflecting the incidence, duration and severity of in-hospital delirium, which is the number of days in-hospital delirium is present in each participant who developed documented in-hospital delirium. Delirium symptoms are observed according to a mean Delirium Observation Screening (DOS) score >3 out of three DOS scale scores/24 hours (indicating significant change), and diagnosed according to meeting the DSM-IV delirium criteria. | Assessed within 1 to 7 days after initiation of the study intervention. | No |
Secondary | The number of days before there is a significant change from baseline in the mean Delirium Observation Screening (DOS) score, and delirium is diagnosed according to the DSM-IV delirium criteria. | Reflecting the time-to-develop delirium, which are the number of days from admission day until the first day delirium is diagnosed, assessed up to the day delirium develops during admission or participant is discharged from hospital. Delirium is diagnosed according to a mean Delirium Observation Screening (DOS) score >3 out of three DOS scale scores/24 hours (indicating significant change), and meeting DSM-IV criteria. | Assessed from 1st day of inclusion, during the 7-day intervention period, up to delirium diagnosis or hospital discharge. | No |
Secondary | The (mean) number of days subjects are admitted to the hospital. | The number of admission days per subject will be used to evaluate the mean hospital length of stay (LOS) in both study arms. The mean LOS is defined by the mean number of days each participant is admitted to hospital, assessed from admission day up to discharge date. | Assessed from 1st day of admission up to hospital discharge. | No |
Secondary | Functionality at baseline according to the Index of Independence in Activities of Daily Living (ADL) | Functionality at baseline will be assessed according to the 6-item Index of Independence in Activities of Daily Living (ADL), administered on admission. Scores rang from 0-6 for both women and men, with higher scores indicating high function/independent. | 1 day of hospital admission. | No |
Secondary | Change from baseline functionality at 3 months according to the Index of Independence in Activities of Daily Living (ADL) | Change from baseline functionality at 3 months after discharge date will be assessed at time point 90 days from hospital discharge date, according to the 6-item Index of Independence in Activities of Daily Living (ADL). | From baseline to assessment at time point 90 days after discharge date. | No |
Secondary | Change from baseline functionality at 6 months according to the Index of Independence in Activities of Daily Living (ADL). | Change in functionality from baseline at 6 months after discharge date will be assessed at time point 180 days from hospital discharge date, according to the 6-item Index of Independence in Activities of Daily Living (ADL). | From baseline to assessment at 180 days after discharge date. | No |
Secondary | Functionality at baseline according to the Instrumental Activities of Daily Living Scale (IADL). | Functionality at baseline will be assessed according to the 8-item Instrumental Activities of Daily Living Scale (IADL), administered on admission. Scores range from 0-8 for women, and 0-5 for men with higher scores indicating high function/independent. | 1 day of hospital admission. | No |
Secondary | Change from baseline functionality at 3 months according to the Instrumental Activities of Daily Living Scale (IADL). | Change from baseline functionality at 3 months after discharge date will be assessed at time point 90 days from hospital discharge date, according to the 8-item Instrumental Activities of Daily Living Scale (IADL). | From baseline to assessment at time point 90 days after discharge date. | No |
Secondary | Change from baseline functionality at 6 months according to the Instrumental Activities of Daily Living Scale (IADL). | Change in functionality from baseline at 6 months after discharge date will be assessed at time point 180 days from hospital discharge date, according to the 8-item Instrumental Activities of Daily Living Scale (IADL). | From baseline to assessment at time point 180 days after discharge date. | No |
Secondary | Mortality during hospital admission. | In-hospital mortality is reflected by the number of deaths (percentage of the total number of subjects included in the study) during hospital admission, assessed up to 30 days from admission date. | From 1st day of admission to the day that in-hospital death from any cause is documented admission, assessed up to hospital discharge. | No |
Secondary | Overall mortality | Overall mortality is reflected by the number of deaths (percentage of the total number of subjects included in the study) from the date of randomization until the assessment time point at 180 days from admission date. | From date of randomization until the date death from any cause is documented, assessed up to 180 days from hospital discharge date. | No |
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