Clinical trial NCT05690698: Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
Official title: Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperactive Delirium
Keywords: Critical Care
Hyperactive Delirium
antipsychotics
Haloperidol
Quetiapine
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel random assignment to receive either oral quetiapine (25-50 mg/day) or haloperidol (1-2 mg/day)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: Day 7
Secondary outcomes:
measure: In-hospital mortality
timeFrame: week 6 from enrollment
measure: ICU-mortality
timeFrame: week 6 from enrollment
measure: Need for MV
timeFrame: week 6 from enrollment
measure: ICU stay
timeFrame: week 6 from enrollment
measure: Hospital stay
timeFrame: week 6 from enrollment
Other outcomes:
measure: Sleeping hours
timeFrame: Day 3
measure: Sleeping hours
timeFrame: Day 7
measure: Delirium Rating Scale-revised-98 severity score
timeFrame: Day 3
measure: Delirium Rating Scale-revised-98 severity score
timeFrame: Day 7
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University Hospitals
Study officials:
affiliation: University of Alexandria
name: Tamer N. Habib, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Suez-canal University
name: Islam E. Ahmed, PharmD
role: STUDY_CHAIR
affiliation: Faculty of Medicine, Gezira University
name: Ibrahim K. Luttfi, PHD
role: STUDY_DIRECTOR
References: