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| Sponsored by: |
UMC Utrecht |
|---|---|
| Information provided by: | UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT00599287 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: Haloperidol Drug: Methylphenidate Drug: Rivastigmine Other: No intervention |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study |
| Official Title: | Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-Blind Pilot Trial |
| Estimated Enrollment: | 80 |
| Study Start Date: | February 2008 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
No intervention
|
Other: No intervention
No intervention
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2: Experimental
Methylphenidate
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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 |
|
3: Experimental
Rivastigmine
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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
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4: Experimental
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)
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | University Medical Center Utrecht ( prof. dr. J. Kesecioglu ) |
| Study ID Numbers: | ICHYPDEL/002, METC-UMCU 07/236 |
| Study First Received: | January 10, 2008 |
| Last Updated: | May 27, 2008 |
| ClinicalTrials.gov Identifier: | NCT00599287 History of Changes |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
ICU delirium Hypoactive delirium Haloperidol |
Methylphenidate Rivastigmine Hypoactive ICU delirium |
|
Dopamine Uptake Inhibitors Neurotransmitter Agents Rivastigmine Psychotropic Drugs Methylphenidate Antiemetics Cholinergic Agents Neuroprotective Agents Haloperidol Signs and Symptoms Dopamine Mental Disorders Dementia Hypokinesia Neurobehavioral Manifestations |
Delirium Tranquilizing Agents Central Nervous System Depressants Central Nervous System Stimulants Confusion Antipsychotic Agents Dyskinesias Cognition Disorders Cholinesterase Inhibitors Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Rivastigmine Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Methylphenidate Antiemetics Cholinergic Agents Neuroprotective Agents Haloperidol Signs and Symptoms Mental Disorders |
Therapeutic Uses Hypokinesia Neurobehavioral Manifestations Delirium Tranquilizing Agents Nervous System Diseases Gastrointestinal Agents Central Nervous System Depressants Enzyme Inhibitors Central Nervous System Stimulants Dopamine Antagonists Confusion Antipsychotic Agents Protective Agents Dyskinesias |
