Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients

Study Overview
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Brief Summary
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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.

Official Title
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Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial

Conditions
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Delirium

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Methylphenidate
* Drug: Rivastigmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>No intervention | |
| Experimental: 2<br>Methylphenidate | Drug: Methylphenidate<br>* Methylphenidate 5 mg. 2 dd 1, oral, increased every day with 10 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 30 mg./day<br>* Other names: Ritalin;|
| Experimental: 3<br>Rivastigmine | Drug: Rivastigmine<br>* Rivastigmine 1,5 mg. 2 dd 1, oral, increased every third day with 3 mg. until negative CAM(-ICU) or side-effects. Maximum dosage 12 mg./day<br>* Other names: Exelon;|
| Experimental: 4<br>Haloperidol | Drug: Haloperidol<br>* Haloperidol 2,5 mg. 2 dd 1, oral. (if patient is 69 years or younger) Haloperidol 1 mg. 2 dd 1, oral (if patient is 70 years or older)<br>* Other names: Haldol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of delirium |  | Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of ICU-stay |  | days | 
| duration of in hospital stay |  | days | 
| delirium severity |  | duration of delirium | 
| frequency of side effects |  | duration of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium