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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Methylphenidate

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

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

3

Rivastigmine

Group Type EXPERIMENTAL

Rivastigmine

Intervention Type DRUG

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

4

Haloperidol

Group Type EXPERIMENTAL

Haloperidol

Intervention Type DRUG

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)

Interventions

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Haloperidol

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)

Intervention Type DRUG

Methylphenidate

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

Intervention Type DRUG

Rivastigmine

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

Intervention Type DRUG

Other Intervention Names

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Haldol Ritalin Exelon

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No