NCT00704301

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

August 13, 2010

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

June 20, 2008

Last Update Submit

August 12, 2010

Conditions

Delirium

Keywords

DeliriumConfusion

Outcome Measures

Primary Outcomes (1)

  • Duration of delirium

    3 months

Secondary Outcomes (10)

  • Severity of delirium

    3 months

  • Use of physical restraints

    3 months

  • Use of escape medication (i.c. Haloperidol or benzodiazepines)

    3 months

  • Number of accidental removed catheters

    3 months

  • Length of ICU stay

    3 months

  • +5 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

RivastigmineDRUG

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.

Also known as: Exelon
1
PlaceboDRUG

Placebo, 2 times a day

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Positive CAM-ICU

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Gelre Hospitals; lukas site

Apeldoorn, Gelderland, 7300 DS, Netherlands

Location

Medical Center Alkmaar

Alkmaar, North Holland, 1800 AM, Netherlands

Location

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

Location

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

University Medical Center Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

Diakonessenhuis

Utrecht, Utrecht, 3582 KE, Netherlands

Location

Related Publications (1)

  • van Eijk MM, Roes KC, Honing ML, Kuiper MA, Karakus A, van der Jagt M, Spronk PE, van Gool WA, van der Mast RC, Kesecioglu J, Slooter AJ. Effect of rivastigmine as an adjunct to usual care with haloperidol on duration of delirium and mortality in critically ill patients: a multicentre, double-blind, placebo-controlled randomised trial. Lancet. 2010 Nov 27;376(9755):1829-37. doi: 10.1016/S0140-6736(10)61855-7. Epub 2010 Nov 4.

    PMID: 21056464DERIVED

MeSH Terms

Conditions

DeliriumConfusion

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Arjen JC Slooter, MD. PhD.

    University Medical Center Utrecht, the Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 20, 2008

First Posted

June 24, 2008

Study Start

November 1, 2008

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

August 13, 2010

Record last verified: 2009-10

Locations

NL(6)