Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
Phase 3
Terminated
- Conditions
- Delirium
- Interventions
- Registration Number
- NCT00599287
- Lead Sponsor
- UMC Utrecht
- Brief Summary
The purpose of this pilot-trial is the feasibility of a large randomized, placebo controlled, doubleblind clinical trial to investigate the use of methylphenidate, rivastigmine or haloperidol in hypoactive ICU-delirium. In addition we will compare duration of delirium, severity of delirium, length of ICU/hospital stay and side effects between the different interventions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Older than 18 years
- Diagnosed as hypoactive delirium
- Informed consent given
Exclusion Criteria
- Pregnancy
- Epilepsy
- M. Parkinson
- Lewy-body dementia
- Prolonged QT-time
- Known allergy to the medicinals used
- Renal replacement therapy
- Hepatic encephalopathy
- Hyperthyroid
- Glaucoma
- Previous suicide attempts
- Syndrome of Gilles de la Tourette
- Patients which cannot receive the medication oral or through a nasogastric tube
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Rivastigmine Rivastigmine 2 Methylphenidate Methylphenidate 4 Haloperidol Haloperidol
- Primary Outcome Measures
Name Time Method duration of delirium Days
- Secondary Outcome Measures
Name Time Method delirium severity duration of delirium frequency of side effects duration of intervention duration of ICU-stay days duration of in hospital stay days
Trial Locations
- Locations (1)
University Medical Center
🇳🇱Utrecht, Netherlands