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Methylphenidate, rivastigmine or haloperidol in hypoactive delirious intensive care patients: a single centre, randomized, mono-blind pilot trial - Methylphenidate, rivastigmine or haloperidol in hypoactive delirious ICU-patients

Methylphenidate, rivastigmine or haloperidol in hypoactive delirious intensive care patients: a single centre, randomized, mono-blind pilot trial - Methylphenidate, rivastigmine or haloperidol in hypoactive delirious ICU-patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003965-42-NL
Enrollment
80
Registered
2007-10-17
Start date
2007-12-04
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Hypoactive delirious ICU-patients MedDRA version: 9.1 Level: LLT Classification code 10012218 Term: Delirium MedDRA version: 9.1 Level: PT Classification code 10012218 Term: Delirium

Interventions

Trade Name: Exelon Product Name: Rivastigmine Product Code: N06DA03 Pharmaceutical Form: Tablet INN or Proposed INN: RIVASTIGMINE CAS Number: 123441032 Current Sponsor code: xx Other descriptive name:

Sponsors

University Medical Centre Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Older than 18 years. Diagnosed as hypoactive delirium 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: Pregnancy; epilepsy; M. Parkinson; Lewy-body dementia; prolonged QT-time; known allergie to the medicinals used; renal replacement therapy; hepatic encephalopathy; hypertheroid; glaucoma; previous suicide attempts; syndrome of Gilles de la Tourette; patients which cannot receive the medication oraly or through a nasogastric tube.

Design outcomes

Primary

MeasureTime frame
Main Objective: The major aim of this pilot trial is to study the feasibility of a large randomized, placebo controlled, dubble blind clinical trial;Secondary Objective: The secondary objectives of this pilot study are to find significant differences between the four interventions (rivastigmine, methylphenidate, haloperidol and no-intervention) on the following outcomes: length of delirium severity of delirium length of ICU stay length of hospital stay dosis of escape medication used;Primary end point(s): - the feasibility of a large RCT (the possibility of inclusion of 80 subjects within one year) - Duration of delirium (hours) - Severity of delirium (DSI score) - length of ICU stay (days) - length of in-hospital stay (days) - use of escape medication (number of dosis per day)—

Countries

Netherlands

Outcome results

None listed

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