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

This study has been terminated.
(Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.)
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00599287
First received: January 10, 2008
Last updated: May 27, 2008
Last verified: February 2008
History of Changes

January 10, 2008
May 27, 2008
February 2008
May 2008   (final data collection date for primary outcome measure)
duration of delirium [ Time Frame: Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00599287 on ClinicalTrials.gov Archive Site
  • duration of ICU-stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • duration of in hospital stay [ Time Frame: days ] [ Designated as safety issue: No ]
  • delirium severity [ Time Frame: duration of delirium ] [ Designated as safety issue: No ]
  • frequency of side effects [ Time Frame: duration of intervention ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients
Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-Blind Pilot Trial

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Delirium
  • 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
  • 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
  • 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
  • Other: No intervention
    No intervention
  • No Intervention: 1
    No intervention
    Intervention: Other: No intervention
  • Experimental: 2
    Methylphenidate
    Intervention: Drug: Methylphenidate
  • Experimental: 3
    Rivastigmine
    Intervention: Drug: Rivastigmine
  • Experimental: 4
    Haloperidol
    Intervention: Drug: Haloperidol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00599287
ICHYPDEL/002, METC-UMCU 07/236
Yes
prof. dr. J. Kesecioglu, University Medical Center Utrecht
UMC Utrecht
Not Provided
Study Director: Jozef Kesecioglu, MD PhD UMC Utrecht
UMC Utrecht
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP