Effects of prophylactic use of haloperidol in critically ill patients with a high risk for delirium

Effects of prophylactic use of haloperidol in critically ill patients with a high risk for delirium - Delirium_Haldol-prophy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39725

Enrollment

2145

Registered

2013-02-22

Start date

2013-06-12

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuropsychiatric disorder acute confusion delirium

Interventions

In this study we have two prophylactic haloperidol groups and one placebo group. Patients allocated to the treatment group will receive either 3x1mg or 3x2mg prophylactic haloperidol until discharge

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All consecutive ICU patients:;- age >= 18 year;- expected length of ICU stay of over one day

Exclusion criteria

Exclusion criteria: - history of epilepsy, Parkinson*s disease, hypokinetic rigid syndrome, dementia or alcohol abuse - patients admitted to the ICU for neurological reasons - patients treated with other anti-psychotics - prolonged QTc-time (over 500msec) or history of ventricular arrhythmia (in last 12 months) - pregnancy - delirious before ICU admission - serious auditory or visual disorders - ICU-stay

Design outcomes

Primary

Measure	Time frame
Primary objective: To determine the effect of prophylactic haloperidol on 28-day mortality	—

Secondary

Measure	Time frame
Secondary Objective(s): There are five secondary outcome measures: 1. To determine the effect of prophylactic haloperidol on 90-day mortality 2. To determine the effect of prophylactic haloperidol on delirium incidence 3. To determine the effect of prophylactic haloperidol on number of delirium-free and coma-free days in a period of 28 days 4. To determine the effect of prophylactic haloperidol on delirium related outcome: duration of mechanical ventilation, incidence of re-intubation, incidence of ICU readmission, and incidence of unplanned removal of tubes and catheters 5. To determine the preventive efficacy of haloperidol in different patient groups based on the a priori risk to develop delirium: patients with a predicted risk up to 50%, 50-70%, 70-90%, above 90% 6. To evaluate side-effects of haloperidol treatment 7. Effect on quality of life	—

Measure

Time frame

Secondary Objective(s): There are five secondary outcome measures: 1. To determine the effect of prophylactic haloperidol on 90-day mortality 2. To determine the effect of prophylactic haloperidol on delirium incidence 3. To determine the effect of prophylactic haloperidol on number of delirium-free and coma-free days in a period of 28 days 4. To determine the effect of prophylactic haloperidol on delirium related outcome: duration of mechanical ventilation, incidence of re-intubation, incidence of ICU readmission, and incidence of unplanned removal of tubes and catheters 5. To determine the preventive efficacy of haloperidol in different patient groups based on the a priori risk to develop delirium: patients with a predicted risk up to 50%, 50-70%, 70-90%, above 90% 6. To evaluate side-effects of haloperidol treatment 7. Effect on quality of life

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)