To assess the efficacy of haloperidol to resolve delirium in adult critically ill patients and thereby render the patient awake and non-delirious.
ID
Source
Brief title
Condition
- Deliria (incl confusion)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Delirium- and coma free days at ICU [up to 14 days after randomisation].
Secondary outcome
To study the efficacy of haloperidol to reduce ICU-delirium associated short-
and long-term burdens (up to one-year), consisting of: 1) mortality; 2)
cognitive and functional impairment; 3) patient- and family experiences and
psychological sequelae during and after ICU stay; 4) safety concerns associated
with haloperidol use.
Background summary
Delirium in critically ill patients is associated with a threefold increase in
mortality risk and delirium duration strongly correlates with cognitive decline
after intensive care unit (ICU) stay. Authoritative evidence-based guidelines
(2013) on integrated pain, agitation and delirium (PAD) management have
therefore proposed to perform screening for delirium symptoms in all critically
ill patients and implement multiple preventive measures for delirium. These
guidelines highlighted the evidence indicating the need for early awakening of
critically ill patients by using less sedation, early as possible trials to
remove the endotracheal tube, active vigilance, prevention and management of
delirium and early mobilisation to effectively reduce both the burdens
associated with delirium and the chance of poor outcomes. These PAD guidelines
and several national (Dutch) guidelines on (ICU) delirium have indicated that
there are no adequately powered trials on efficacy of haloperidol for the
treatment of ICU delirium and associated adverse outcomes.
Study objective
To assess the efficacy of haloperidol to resolve delirium in adult critically
ill patients and thereby render the patient awake and non-delirious.
Study design
Prospective, multicentre, double-blind placebo-controlled randomized
intervention study.
Intervention
Haloperidol versus placebo in delirious critically ill patients starting with
2.5mg IV q8h and titrated to maximum 5mg IV q8h.
Study burden and risks
The burden associated with participation will include cognitive, functional and
psychological assessments at 3 and 12 months. The associated risk of
participation is estimated to be negligible, since the study drug is already
common practice and surveillance will due to study procedures increase,
enhancing rather then impeding safety in relation to the study drug.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for eligibility:
1. Age >= 18 years
2. Admitted to one of six participating ICUs of the EuRIDICE trial.;Inclusion criteria for randomisation:
1. Delirium, as assessed with the Intensive Care Delirium Screening Checklist - ICDSC: >=4 or Confusion Assessment Method for the ICU - CAM-ICU: positive). NB Delirium can occur in the course of ICU admission or be present at admission.
2. Written Informed Consent is obtained from patient or legal representative
3. Complies with inclusion criteria but NOT exclusion criteria for eligibility (See above and exclusion criteria)
Exclusion criteria
Exclusion criteria for eligibility:
1. Admitted to ICU with a neurological diagnosis (such as acute stroke, traumatic brain injury, intracranial malignancy, anoxic coma). Previous non-acute stroke or other previous neurological condition without cognitive deterioration is not an exclusion criterion.
2. Pregnancy (to be excluded by pregnancy test in women of child baring age)
3. History of ventricular arrhythmia including *torsade de pointes* (TdP)
4. Known allergy to haloperidol
5. History of dementia or an Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) score >= 4
6. History of malignant neuroleptic syndrome or parkinsonism (either Parkinson*s disease or another hypokinetic rigid syndrome)
7. Schizophrenia
8. Inability to conduct valid delirium screening assessment (e.g. coma, deaf, blind) or inability to speak Dutch
9. The patient is expected to die within 24 hours, or is expected to leave the ICU within 24 hours after evaluation (may be reassessed daily);Exclusion criteria for randomisation:
1. Prolonged QT-interval (QTc > 500ms)
2. (recent) *torsade de pointes* (TdP)
3. (recent) malignant neuroleptic syndrome or parkinsonism
4. Evidence of acute alcohol (or substance) withdrawal requiring pharmacological intervention (e.g. benzodiazepines or alfa-2 agonist) to treat
5. IQCODE not assessed in patients >= 50 years old or with possible cognitive deterioration
6. The patient is expected to die within 24 hours.
7. No (previously) signed informed consent by patient or representative
8. Current participation in another intervention trial that is evaluating a medication, device or behavioural intervention
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003115-20-NL |
| CCMO | NL62689.078.17 |
| OMON | NL-OMON26510 |