Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients - Full Text View

Sponsor:	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:	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:

MedlinePlus related topics: Delirium

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Methylphenidate Rivastigmine SDZ-ENA 713 Methylphenidate hydrochloride

U.S. FDA Resources

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

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 February 09, 2012