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

UMC Utrecht

Status and phase: Terminated; Phase 3

Conditions: Delirium

Treatments: Drug: Rivastigmine; Drug: Haloperidol; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT00599287

METC-UMCU 07/236

ICHYPDEL/002

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

1

No Intervention group

Description:

No intervention

2

Experimental group

Description:

Methylphenidate

Treatment:

Drug: Methylphenidate

3

Experimental group

Description:

Rivastigmine

Treatment:

Drug: Rivastigmine

4

Experimental group

Description:

Haloperidol

Treatment:

Drug: Haloperidol