Back to resultsMethylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
Primary Purpose
Delirium
Status
Terminated
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Haloperidol
Methylphenidate
Rivastigmine
Sponsored by
About this trial
This is an interventional treatment trial for Delirium focused on measuring ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium
Eligibility 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
Sites / Locations
- University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
No intervention
Methylphenidate
Rivastigmine
Haloperidol
Outcomes
Primary Outcome Measures
duration of delirium
Secondary Outcome Measures
duration of ICU-stay
duration of in hospital stay
delirium severity
frequency of side effects
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00599287
Brief Title
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
Official Title
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.
Study Start Date
February 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UMC Utrecht
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
ICU delirium, Hypoactive delirium, Haloperidol, Methylphenidate, Rivastigmine, Hypoactive ICU delirium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
2
Arm Type
Experimental
Arm Description
Methylphenidate
Arm Title
3
Arm Type
Experimental
Arm Description
Rivastigmine
Arm Title
4
Arm Type
Experimental
Arm Description
Haloperidol
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
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
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
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
Intervention Name(s)
Rivastigmine
Other Intervention Name(s)
Exelon
Intervention Description
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
Primary Outcome Measure Information:
Title
duration of delirium
Time Frame
Days
Secondary Outcome Measure Information:
Title
duration of ICU-stay
Time Frame
days
Title
duration of in hospital stay
Time Frame
days
Title
delirium severity
Time Frame
duration of delirium
Title
frequency of side effects
Time Frame
duration of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jozef Kesecioglu, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center
City
Utrecht
ZIP/Postal Code
3508 GA
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
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