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

Tracking Information

First Received Date ^ICMJE

January 10, 2008

Last Updated Date

May 27, 2008

Start Date ^ICMJE

February 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

duration of delirium [ Time Frame: Days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00599287 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-Blind Pilot Trial

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study

Condition ^ICMJE

Delirium

Intervention ^ICMJE

Drug: Haloperidol
Drug: Methylphenidate
Drug: Rivastigmine
Other: No intervention

Study Arms / Comparison Groups

No Intervention: No intervention
Experimental: Methylphenidate
Experimental: Rivastigmine
Experimental: Haloperidol

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00599287

Responsible Party

prof. dr. J. Kesecioglu, University Medical Center Utrecht

Study ID Numbers ^ICMJE

ICHYPDEL/002, METC-UMCU 07/236

Study Sponsor ^ICMJE

UMC Utrecht

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jozef Kesecioglu, MD PhD

University Medical Center Utrecht

Information Provided By

UMC Utrecht

Verification Date

February 2008

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