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

Conditions: Hypoactive delirious ICU-patients
MedDRA version: 9.1Level: LLTClassification code 10012218Term: Delirium
MedDRA version: 9.1Level: PTClassification code 10012218Term: Delirium

Registration Number: EUCTR2007-003965-42-NL

Lead Sponsor: niversity Medical Centre Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>length of delirium<br>severity of delirium<br>length of ICU stay<br>length of hospital stay<br>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)<br>- Duration of delirium (hours)<br>- Severity of delirium (DSI score)<br>- length of ICU stay (days)<br>- length of in-hospital stay (days)<br>- use of escape medication (number of dosis per day)

Secondary Outcome Measures