Status:
RECRUITING
HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial
Lead Sponsor:
Tan Tock Seng Hospital
Conditions:
Haloperidol
Advanced Cancer
Eligibility:
All Genders
21-99 years
Phase:
PHASE3
Brief Summary
1. Background and Clinical Need: Delirium is common at the end of life and is challenging to control. There is a clinical need to study the benefits of commonly used drugs like Haloperidol and Ola...
Detailed Description
(A) Background \& Clinical Need Delirium is commonly encountered in palliative care with a prevalence of between 26-74% and rising to as high as 88% nearer the end of life (2). It negatively impacts ...
Eligibility Criteria
Inclusion
- Patients with advanced cancer or end-stage organ disease
- Age ≥ 21 years old
- Fulfil All Three Diagnosis of Delirium:
- Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium
- Memorial Delirium Assessment Scale (MDAS)©1996 \>/= 13
- Richmond Agitation-Sedation Scale (RASS) Score +1 to +3
- Able to consume medications orally
- Prognosis \> 48 hrs (Clinician Estimate)
Exclusion
- Parkinson's Disease or Vascular Parkinsonism
- Patient with dementia
- Chronic Schizophrenia on regular Anti-psychotic medications
- Taking any regular Benzodiazepines\* or any Anti-psychotic\*\* medications
- Known allergy to Haloperidol or Olanzapine
- History of Substance Abuse
- Known Prolonged corrected QT interval (QTc) Syndrome (In Patient's Medical History)
- Prognosis \< 48 hours (Clinician's Estimate)
- Unable to consume oral medications
- Richmond Agitation and Sedation Scale (RASS) Score +4 (Too agitated and will require Parenteral Anti-psychotics and/or Benzodiazepines)
- Pregnancy \* e.g. Lorazepam, Alprazolam, Clonazepam, Midazolam \*\*e.g. Haloperidol, Risperidone, Quetiapine, Olanzapine
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04833023
Start Date
May 18 2022
End Date
December 1 2024
Last Update
April 12 2024
Active Locations (3)
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1
Tan Tock Seng Hospital
Singapore, Singapore, 308433
2
Dover Park Hospice
Singapore, Singapore, 308436
3
St. Andrew's Community Hospital
Singapore, Singapore, 529895