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

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ClinicalTrials.gov Identifier: NCT00599287
Recruitment Status : Terminated (Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.)
First Posted : January 23, 2008
Last Update Posted : May 29, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Delirium Drug: Haloperidol Drug: Methylphenidate Drug: Rivastigmine Other: No intervention Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-Blind Pilot Trial
Study Start Date : February 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008


Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
No intervention
Other: No intervention
No intervention
Experimental: 2
Methylphenidate
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
Other Name: Ritalin
Experimental: 3
Rivastigmine
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
Other Name: Exelon
Experimental: 4
Haloperidol
Drug: 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)
Other Name: Haldol


Outcome Measures

Primary Outcome Measures :
  1. duration of delirium [ Time Frame: Days ]

Secondary Outcome Measures :
  1. duration of ICU-stay [ Time Frame: days ]
  2. duration of in hospital stay [ Time Frame: days ]
  3. delirium severity [ Time Frame: duration of delirium ]
  4. frequency of side effects [ Time Frame: duration of intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599287


Locations
Netherlands
University Medical Center
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
Study Director: Jozef Kesecioglu, MD PhD UMC Utrecht
More Information

Responsible Party: prof. dr. J. Kesecioglu, University Medical Center Utrecht
ClinicalTrials.gov Identifier: NCT00599287     History of Changes
Other Study ID Numbers: ICHYPDEL/002
METC-UMCU 07/236
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: May 29, 2008
Last Verified: February 2008

Keywords provided by UMC Utrecht:
ICU delirium
Hypoactive delirium
Haloperidol
Methylphenidate
Rivastigmine
Hypoactive ICU delirium

Additional relevant MeSH terms:
Delirium
Hypokinesia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Methylphenidate
Haloperidol
Rivastigmine
Haloperidol decanoate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs