HALO Trial: Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients; A Multi-Centre, Randomised-Controlled Trial

Launched by TAN TOCK SENG HOSPITAL · Apr 5, 2021

Keywords

ClinConnect Summary

The HALO Trial is studying two medications, Haloperidol and Olanzapine, to see which is more effective in treating hyperactive delirium in patients with advanced cancer or severe organ disease who are receiving palliative care. Hyperactive delirium can cause confusion, restlessness, and agitation in patients nearing the end of life, making it important to find effective treatments. The trial aims to compare these two commonly used drugs to determine if Olanzapine can manage symptoms as well as Haloperidol, but with potentially fewer side effects.

To participate in the trial, patients must be at least 21 years old, have advanced cancer or end-stage organ disease, and display certain signs of delirium. They should also be able to take medications by mouth and have a life expectancy of more than 48 hours. Participants will receive either Haloperidol or Olanzapine, and their symptoms will be monitored over several hours and days to see how well each medication works. This study is important because it could provide valuable insights into how to effectively manage delirium in palliative care, ultimately improving the quality of life for patients and their families.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with advanced cancer or end-stage organ disease
• • 2. Age ≥ 21 years old
• 3. 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
• • 4. Able to consume medications orally
• • 5. Prognosis \> 48 hrs (Clinician Estimate)
• Exclusion Criteria:
• • 1. Parkinson's Disease or Vascular Parkinsonism
• • 2. Patient with dementia
• • 3. Chronic Schizophrenia on regular Anti-psychotic medications
• • 4. Taking any regular Benzodiazepines\* or any Anti-psychotic\*\* medications
• • 5. Known allergy to Haloperidol or Olanzapine
• • 6. History of Substance Abuse
• • 7. Known Prolonged corrected QT interval (QTc) Syndrome (In Patient's Medical History)
• • 8. Prognosis \< 48 hours (Clinician's Estimate)
• • 9. Unable to consume oral medications
• • 10. Richmond Agitation and Sedation Scale (RASS) Score +4 (Too agitated and will require Parenteral Anti-psychotics and/or Benzodiazepines)
• • 11. Pregnancy \* e.g. Lorazepam, Alprazolam, Clonazepam, Midazolam \*\*e.g. Haloperidol, Risperidone, Quetiapine, Olanzapine