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

NCT00599287 | Terminated Phase 3 DMC

• 2 other identifiers: ICHYPDEL/002METC-UMCU 07/236
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

ICU delirium; Hypoactive delirium; Haloperidol; Methylphenidate; Rivastigmine; Hypoactive ICU delirium

Outcome Measures

Primary Outcomes (1)

• duration of delirium

  Days

Secondary Outcomes (4)

• duration of ICU-stay

  days

• duration of in hospital stay

  days

• delirium severity

  duration of delirium

• frequency of side effects

  duration of intervention

Study Arms (4)

1

NO INTERVENTION

No intervention

2

EXPERIMENTAL

Methylphenidate

Drug: Methylphenidate

3

EXPERIMENTAL

Rivastigmine

Drug: Rivastigmine

4

EXPERIMENTAL

Haloperidol

Drug: Haloperidol

Interventions

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)

Also known as: Haldol

4

Methylphenidate DRUG

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

Also known as: Ritalin

2

Rivastigmine DRUG

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

Also known as: Exelon

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Diagnosed as hypoactive delirium
• Informed consent given

You may not qualify if:

• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Delirium

Interventions

Haloperidol; Methylphenidate; Rivastigmine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylcarbamates; Carbamates; Acids, Acyclic

Study Officials

• Jozef Kesecioglu, MD PhD

  UMC Utrecht

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2008
• First Posted: January 23, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: March 21, 2018

Record last verified: 2008-02

Locations

NL (1)