Faculty of Medicine, Alexandria University Hospitals
Alexandria, Egypt
NCT Number: NCT05690698
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 3
Alexandria, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atypical antipsychotic
Antipsychotic
Time frame: 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
Time frame: week 6 from enrollment
In-hospital all cause mortality
Time frame: week 6 from enrollment
ICU all cause mortality
Time frame: week 6 from enrollment
Need for mechanical ventilation during ICU stay
Time frame: week 6 from enrollment
Number of days of ICU stay
Time frame: week 6 from enrollment
Number of days of hospital stay
Time frame: Day 3
Sleeping hours per night
Time frame: Day 7
Sleeping hours per night
Time frame: 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
Time frame: Day 7
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
Alexandria University
Other
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