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Rivastigmine for Intensive Care Unit (ICU) Delirium

This study has been terminated.
(The study is prematurely terminated due to a safety issue)
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Novartis
Hersenstichting
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00704301
First received: June 20, 2008
Last updated: August 12, 2010
Last verified: October 2009
  Purpose

Delirium in Intensive Care (IC) patients is a frequent disorder. The aim of this study is to investigate whether treatment of delirium in the ICU with rivastigmine added to haloperidol shortens the duration of delirium in comparison to placebo added to the treatment with haloperidol.


Condition Intervention Phase
Delirium
Drug: Rivastigmine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rivastigmine for Delirium in Intensive Care Patients, a Double-blind, Randomized Placebo-controlled add-on Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Duration of delirium [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severity of delirium [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Use of physical restraints [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Use of escape medication (i.c. Haloperidol or benzodiazepines) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of accidental removed catheters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of ICU stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Length of in-hospital stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cognitive outcomes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Activity of daily living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Healthcare costs [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Frequency and distribution of side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: November 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Rivastigmine: two times 1,5 mg a day; The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
Drug: Rivastigmine
Rivastigmine, two times 1,5 mg a day. The dosage will be increased every three days with 3 mg a day, until the CAM-ICU is negative or until the occurrence of presumed severe adverse effects or until a maximum of 12 mg a day.
Other Name: Exelon
Placebo Comparator: 2
Haloperidol: aged 70 years or less: 1 mg haloperidol three times a day i.v. older than 70 years: 0,5 mg haloperidol three times a day i.v. Placebo: 2 times a day
Drug: Placebo
Placebo, 2 times a day

Detailed Description:

Objective: To study whether rivastigmine added to treatment with haloperidol shortens the duration of delirium in ICU patients and reduces costs.

Study design: Multicentre, double-blind, randomized controlled trial. Study population: Consecutive adult ICU patients with delirium according to the CAM-ICU.

Intervention: Increasing dosage of rivastigmine or placebo as add-on medication.

Primary study parameters: Duration of delirium. Secondary study parameters: Delirium severity, length of ICU and hospital stay, functional status and mortality after 3 months.

Sample size: 440 patients will be included. Economic evaluation: includes a comparison of direct and indirect medical costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Burden: questionnaires (duration: 30 minutes). Risk: possible exposure to drug not indicated for the disorder. Benefit: possible treatment with according to experts possible beneficial drug. Consideration: The investigators of this study believe that the burden and risk do not exceed the expected benefit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Positive CAM-ICU

Exclusion Criteria:

  • Known allergy to rivastigmine
  • Unable to receive enteric medication
  • Pregnant or lactating
  • Renal replacement therapy
  • Hepatic encephalopathy
  • Second or third degree atrioventricular block
  • Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
  • Parkinson's disease.
  • Lewy body dementia.
  • ECG QT interval above 500 msec.
  • No informed consent
  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: NCT00704301

Locations
Netherlands
Medical Center Leeuwarden
Leeuwarden, Friesland, Netherlands, 8901 BR
Gelre Hospitals; lukas site
Apeldoorn, Gelderland, Netherlands, 7300 DS
Medical Center Alkmaar
Alkmaar, Noord-Holland, Netherlands, 1800 AM
Erasmus Medical Center
Rotterdam, Zuid-Holland, Netherlands, 3000 CA
Diakonessenhuis
Utrecht, Netherlands, 3582 KE
University Medical Center Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
ZonMw: The Netherlands Organisation for Health Research and Development
Novartis
Hersenstichting
Investigators
Principal Investigator: Arjen JC Slooter, MD. PhD. University Medical Center Utrecht, the Netherlands
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. A.J.C. Slooter, university Medical Center Utrecht, the Netherlands
ClinicalTrials.gov Identifier: NCT00704301     History of Changes
Other Study ID Numbers: IC-DEL/009
Study First Received: June 20, 2008
Last Updated: August 12, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Delirium
Confusion

Additional relevant MeSH terms:
Delirium
Confusion
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Rivastigmine
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014