Hyperactive Delirium
Conditions
Keywords
Critical Care, Hyperactive Delirium, antipsychotics, Haloperidol, Quetiapine
Brief summary
In population of intensive care unit (ICU), most studies compared atypical antipsychotics such as quetiapine with the traditional haloperidol in delirious patients of various forms and etiologies. The role of such agents in patients with hyperactive is not fully understood. This study compares the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in the intensive care unit, and mortality in critically ill patients.
Detailed description
A common complication in the intensive care unit (ICU) that has recently been identified is delirium. Defining delirium as a sudden deterioration in attention, awareness, and cognition, which is not explained by any pre-existing neurocognitive disorder, but because of another medical condition, the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) clarified the definition of delirium. A dibenzothiazepine derivative with a novel and distinctive pharmacologic profile is quetiapine. The limbic system is overactive in delirium, which is one of its pathophysiologies. By obstructing the mesolimbic dopamine D2 receptors specifically, quetiapine may be able to regulate this hyperactivity. The objective of this study is to compare the effectiveness of quetiapine with haloperidol in treating the hyperactive form of delirium in terms of their effects on morbidity, length of stay in ICU, and mortality in critically ill patients. This research will not receive any grants, funding, or financial aid (NOT FUNDED STUDY). Collaborators declare that they have no conflicts of interest.
Interventions
DRUGQuatiapine
Atypical antipsychotic
DRUGHaloperidol
Antipsychotic
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blinded trial
Intervention model description
Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients who are diagnosed with hyperactive form of delirium during their ICU stay using CAM-ICU tool (the confusion assessment method for the intensive care unit)
Exclusion criteria
* Suspected substance-induced delirium * Previous use of antipsychotics * Known allergy or intolerance to the study drugs * Pregnancy or breast feeding * Acute renal injury * Hepatic failure * Inability to tolerate oral drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Day 7 | Response rate is defined as a reduction of the DRS-R-98 severity score from its baseline for 50% or more and a DRS-R-98 severity score of 12 or less without relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital mortality | week 6 from enrollment | In-hospital all cause mortality |
| ICU-mortality | week 6 from enrollment | ICU all cause mortality |
| Need for MV | week 6 from enrollment | Need for mechanical ventilation during ICU stay |
| ICU stay | week 6 from enrollment | Number of days of ICU stay |
| Hospital stay | week 6 from enrollment | Number of days of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleeping hours | Day 3 | Sleeping hours per night |
| Delirium Rating Scale-revised-98 severity score | Day 3 | The DRS-R-98 is a valid measure of delirium severity over a broad range of symptoms and is a useful diagnostic and assessment tool, maximum severity score of 39 points |
Countries
Egypt
Outcome results
None listed