Methylphenidate, Rivastigmine or Haloperidol in Hypoactiv... | NCT00599287

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

NCT00599287

Sponsor

UMC Utrecht

Status

Terminated

Last Update Posted

Mar 21, 2018Actual

Enrollment

80Estimated

Phase

Phase 3

Conditions

Delirium

Interventions

Haloperidol
Methylphenidate
Rivastigmine

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
METC-UMCU 07/236

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inclusion rate too low due to a lack of eligible patients and difficulties obtaining informed consent.

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jan 10, 2008

First Submission Date that Met QC Criteria

Jan 22, 2008

First Posted Date

Jan 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2018

Last Update Posted Date

Mar 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	No intervention
2	Experimental	Methylphenidate	Drug: Methylphenidate
3	Experimental	Rivastigmine	Drug: Rivastigmine
4	Experimental	Haloperidol	Drug: Haloperidol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Haloperidol	Drug	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)	4

Measure	Description	Time Frame
duration of delirium		Days

Measure	Description	Time Frame
duration of ICU-stay		days
duration of in hospital stay		days
delirium severity

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jozef Kesecioglu, MD PhD	UMC Utrecht	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center		Utrecht		3508 GA	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006220	Haloperidol
D008774	Methylphenidate
D000068836	Rivastigmine

Ancestor Terms

ID	Term
D002090	Butyrophenones
D007659	Ketones
D009930	Organic Chemicals
D010648	Phenylacetates

Browse Leaves

Not provided

Browse Branches

Not provided