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A randomised, double-blind, placebo-controlled trial to compare the early administration of intravenous haloperidol versus placebo in the prevention and treatment of delirium in critically ill ventilated patients - HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

A randomised, double-blind, placebo-controlled trial to compare the early administration of intravenous haloperidol versus placebo in the prevention and treatment of delirium in critically ill ventilated patients - HalOPeridol Effectiveness in ICU delirium - the HOPE-ICU trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-017842-30-GB
Enrollment
142
Registered
2010-07-23
Start date
2010-09-17
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Delirium

Interventions

Trade Name: Haloperidol Pharmaceutical Form: Solution for injection INN or Proposed INN: Haloperidol CAS Number: 52-86-8 Concentration u

Sponsors

West Hertfordshire Hospitals NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Mechanically ventilated patients in the Intensive Care Unit within 72 hours of admission. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Allergy to haloperidol, chronic antipsychotic use, corrected QTc interval (QTc) over 500 msecs, history of torsades de pointes or neuroleptic malignant syndrome, age less than 18 years, pregnancy, structural brain damage, patients with dementia, patients with Parkinsons Disease, moribund patients not expected to survive 48 hours, patients who do not understand English, patients predicted to stay less than 48 hours, and elective uncomplicated surgery.

Design outcomes

Primary

MeasureTime frame
Main Objective: Knowing that critically ill patients who need to be on ventilators are at high risk of delirium , does giving them haloperidol decrease the length of time they are delirious for?;Secondary Objective: The secondary aims of this study are to examine other important clinical outcomes i.e.the number of patients who become delirious, how many die, how long they are in hospital for, brain function at 6 months, quality of life after discharge, safety and cost-effectiveness.;Primary end point(s): Delirium/coma free days at 14 days.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026