Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833023
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2021-03-30
Brief Title:
HALO Trial Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients A Multi-Centre Randomised-Controlled Trial
Sponsor:
Tan Tock Seng Hospital
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
HALO Trial Haloperidol vs Olanzapine in Hyperactive Delirium in Palliative Care Patients A Multi-Centre Randomised-Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner
2 AimsHypotheses
The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium
3 Methods
The investigators will conduct a pragmatic multi-centre hospital inpatient hospice community hospital open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium
The primary outcome is the change in Richmond Agitation and Sedation Scale RASS scores among patients in each treatment group at 8 hours post-drug administration
The secondary outcome is the control of hyperactive delirium at 24 48 and 72 hours using either Haloperidol or Olanzapine
The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications survival after enrolment into study will also be studied
4 Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease
Haloperidol is used traditionally in palliative care for managing delirium However as a conventional anti-psychotic it does cause extra-pyramidal side-effects Olanzapine a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium These 2 commonly used drugs have never been compared head to head in a randomised-controlled multi-centre study
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 Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients in a scientifically robust manner
2 AimsHypotheses
The investigators aim to study the effectiveness of Haloperidol compared with Olanzapine in the management of hyperactive delirium in advanced cancer or end-stage organ disease patients receiving palliative care The investigators hypothesise that Olanzapine is as effective as Haloperidol in the control of hyperactive delirium
3 Methods
The investigators will conduct a pragmatic multi-centre hospital inpatient hospice community hospital open-label randomised-controlled trial comparing the use of Haloperidol versus Olanzapine in advanced cancer or end-stage organ disease patients with hyperactive delirium
The primary outcome is the change in Richmond Agitation and Sedation Scale RASS scores among patients in each treatment group at 8 hours post-drug administration
The secondary outcome is the control of hyperactive delirium at 24 48 and 72 hours using either Haloperidol or Olanzapine
The mean doses of Haloperidol and Olanzapine used as well as the volume of rescue Midazolam required as well as side-effects of the study medications survival after enrolment into study will also be studied
4 Significance to palliative care The results of this study will advance the knowledge of delirium management worldwide with regards to the efficacy of Haloperidol and Olanzapine in managing hyperactive delirium in patients with advanced cancer or end-stage organ disease
Haloperidol is used traditionally in palliative care for managing delirium However as a conventional anti-psychotic it does cause extra-pyramidal side-effects Olanzapine a newer atypical anti-psychotic with a more favourable side-effect profile is being used increasingly in the control of delirium These 2 commonly used drugs have never been compared head to head in a randomised-controlled multi-centre study
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 patient care and leads to greater morbidity and mortality 3 There are 3 sub-types of delirium - hyperactive mixed and hypoactive 4 with majority of well-designed studies in palliative care focusing on the management of delirium as a whole 5 However recently published literature suggests that these delirium subtypes appear to have different trajectories and are also generally treated differently 6
Overall the management of delirium in palliative care remains controversial Agar had shown in a randomised controlled trial that supportive care may be superior to the use of anti-psychotics even though the patients in Agars study were only mildly delirious and the overall doses of anti-psychotics used was lower than compared to common practice 9 Other studies have shown the benefits of anti-psychotics like haloperidol olanzapine and aripiprazole in the management of delirium 1011
Hui et al was the only study which looked at the management of hyperactive delirium in the palliative care setting 7 Patients with hyperactive delirium exhibit restlessness agitation and even aggression towards their loved ones and to healthcare providers caring for them 8
To date there have not been any multi-centre randomised-controlled trial which has addressed the effectiveness of oral Haloperidol vs Olanzapine in the management of hyperactive delirium in the palliative care setting
B Specific Aims
The investigators aim to study the effectiveness of Olanzapine vs Haloperidol in the management of hyperactive delirium in patients with advanced cancer or end-stage organ disease in 3 different settings
The primary outcome is the change in Richmond Agitation and Sedation Scale RASS scores among patients in each treatment group at 8 hours after the administration of Haloperidol or Olanzapine as measured using the Richmond Agitation and Sedation Scale RASS
The secondary outcome is the change in Richmond Agitation and Sedation Scale RASS score at 24 48 and 72 hours with the use of either Haloperidol or Olanzapine required
The mean doses of Haloperidol and Olanzapine used as well as the doses of rescue Midazolam required as well as side-effects of the study medications survival after enrolment into study will also be studied
C Methods
Study Design
The investigators aim to conduct a multi-centre randomised-controlled open-label trial Acute Hospital Palliative Care Unit Palliative Care Unit in Community Hospital and Inpatient Hospice comparing the use of haloperidol vs olanzapine in a 11 ratio in advanced cancer or end-stage organ disease patients with hyperactive delirium Patients will be followed up for 3 days 72 hours with regards to the response to study medications as well as other factors and outcomes as described below Mortality data will also be collected
The study will be conducted in 3 different Palliative Care Centres in Singapore - 1 Tan Tock Seng Hospital Acute Palliative Care Unit 2 Palliative Care Unit in St Andrews Community Hospital and 3 Dover Park Hospice This is to increase the pragmatic applicability and external validity in this study to different palliative care units in Singapore and internationally
Informed consent will be taken from the patients legal representative according to the HBR Act as the patients recruited will be delirious and therefore will not able to provide informed consent adequately
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 patient care and leads to greater morbidity and mortality 3 There are 3 sub-types of delirium - hyperactive mixed and hypoactive 4 with majority of well-designed studies in palliative care focusing on the management of delirium as a whole 5 However recently published literature suggests that these delirium subtypes appear to have different trajectories and are also generally treated differently 6
Overall the management of delirium in palliative care remains controversial Agar had shown in a randomised controlled trial that supportive care may be superior to the use of anti-psychotics even though the patients in Agars study were only mildly delirious and the overall doses of anti-psychotics used was lower than compared to common practice 9 Other studies have shown the benefits of anti-psychotics like haloperidol olanzapine and aripiprazole in the management of delirium 1011
Hui et al was the only study which looked at the management of hyperactive delirium in the palliative care setting 7 Patients with hyperactive delirium exhibit restlessness agitation and even aggression towards their loved ones and to healthcare providers caring for them 8
To date there have not been any multi-centre randomised-controlled trial which has addressed the effectiveness of oral Haloperidol vs Olanzapine in the management of hyperactive delirium in the palliative care setting
B Specific Aims
The investigators aim to study the effectiveness of Olanzapine vs Haloperidol in the management of hyperactive delirium in patients with advanced cancer or end-stage organ disease in 3 different settings
The primary outcome is the change in Richmond Agitation and Sedation Scale RASS scores among patients in each treatment group at 8 hours after the administration of Haloperidol or Olanzapine as measured using the Richmond Agitation and Sedation Scale RASS
The secondary outcome is the change in Richmond Agitation and Sedation Scale RASS score at 24 48 and 72 hours with the use of either Haloperidol or Olanzapine required
The mean doses of Haloperidol and Olanzapine used as well as the doses of rescue Midazolam required as well as side-effects of the study medications survival after enrolment into study will also be studied
C Methods
Study Design
The investigators aim to conduct a multi-centre randomised-controlled open-label trial Acute Hospital Palliative Care Unit Palliative Care Unit in Community Hospital and Inpatient Hospice comparing the use of haloperidol vs olanzapine in a 11 ratio in advanced cancer or end-stage organ disease patients with hyperactive delirium Patients will be followed up for 3 days 72 hours with regards to the response to study medications as well as other factors and outcomes as described below Mortality data will also be collected
The study will be conducted in 3 different Palliative Care Centres in Singapore - 1 Tan Tock Seng Hospital Acute Palliative Care Unit 2 Palliative Care Unit in St Andrews Community Hospital and 3 Dover Park Hospice This is to increase the pragmatic applicability and external validity in this study to different palliative care units in Singapore and internationally
Informed consent will be taken from the patients legal representative according to the HBR Act as the patients recruited will be delirious and therefore will not able to provide informed consent adequately
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None