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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-Blind Pilot Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • duration of delirium [ Time Frame: Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 10, 2008
Last Updated: May 27, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dyskinesias
Haloperidol
Haloperidol decanoate
Methylphenidate
Rivastigmine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014