Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prophylactic Haloperidol Use for Delirium in ICU Patients; a Randomized Placebo-controlled Double-blind Multicentre Trial
Brief Summary: The aim of this study is to determine the effects of a low dosage of prophylactic haloperidol in patients with a high risk to develop delirium, defined by an expected ICU length of stay of \>1 day. The investigators hypothesized that haloperidol prophylaxis in patients with a high risk for delirium reduces 28-day mortality, delirium and delirium related outcome.

Two different dosages of haloperidol are used in this study to compare with placebo. A dosage of 1mg, or 2mg or placebo three times a day in a double-blinded fashion resulting in a three-armed multicentre randomized double-blinded placebo-controlled trial. To relate the potential beneficial effects of haloperidol to the a priori risk to develop delirium, the PREDELIRIC-model (delirium prediction model for ICU patients) will be used. This will enable the investigators to determine the preventive efficacy of haloperidol in patient groups based on their risk to develop delirium.


Options:
A: Inclusion Criteria:

* 18 years of age or over
* Mechanically ventilated, with anticipated need for MV ≥48 hrs
* ICU team has decided to initiate continuous sedative/analgesic infusion(s)
* informed consent from patient and/or SDM

Exclusion Criteria

* Admission after resuscitation from cardiac arrest
* Traumatic brain injury
* Currently receiving neuromuscular blocking agents
* Allergy to midazolam and lorazepam
* Lack of commitment to aggressive treatment
* Previous enrolment in SLEAP, or current enrolment in related trial
B: Inclusion Criteria:

* age ≥ 18
* expected length of ICU stay of over one day

Exclusion Criteria:

* history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, dementia or alcohol withdrawal syndrome
* patients admitted to the ICU for neurological reasons (including post-resuscitation patients)
* patients treated with other anti-psychotics
* prolonged QTc-time (\>500msec) or history of serious ventricular arrhythmia (in last 12 months)
* pregnancy/breast feeding
* delirious before ICU admission
* serious auditory or visual disorders
* ICU-stay ≤1 day
* unable to understand Dutch
* severely mentally disabled
* serious receptive aphasia
* moribund and not expected to survive 2 days
* known allergy to haloperidol
C: Inclusion Criteria:

* Patients were included in the study if they were 18 years of age or older,
* mechanically ventilated,
* placed on the institutional sedation protocol,
* expected to require sedation lasting 24 hours after randomization, and
* admitted to the TSICU and followed by the Trauma/Surgical Service.

Exclusion Criteria:

Patients were excluded for any of the following:

* 72 hours or greater since sedation protocol initiation,
* treatment per the institutional traumatic brain injury (TBI) protocol,
* concomitant continuous infusion of a neuromuscular blocking agent,
* heart rate less than 50 beats per minute,
* mean arterial pressure less than 55 mmHg despite fluid resuscitation and vasopressors, and
* use of other alpha-2 agonists within 24 hours of randomization.
D: Inclusion Criteria

1. Patients intubated and mechanical ventilated for \< 72 hours
2. Age \> 18 years
3. Baseline independent functional status as assessed by a Barthel Index score \> 70 collected from a proxy reflecting baseline health 2 weeks prior to critical illness

Exclusion Criteria

1. Rapidly evolving neurological/neuromuscular disease
2. Cardiac arrest
3. Irreversible conditions with six month mortality estimated at \> 50%
4. Elevated intracranial pressure
5. Multiple absent limbs (precluding complete musculoskeletal examination)
6. Enrollment in another trial

Answer: B