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Clinical Trials/NCT00599287
NCT00599287
Terminated
Phase 3

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

UMC Utrecht1 site in 1 country80 target enrollmentFebruary 2008
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ConditionsDelirium
InterventionsMethylphenidateRivastigmineHaloperidol
DrugsHaloperidolMethylphenidateRivastigmine

Overview

Phase
Phase 3
Intervention
Methylphenidate
Conditions
Delirium
Sponsor
UMC Utrecht
Enrollment
80
Locations
1
Primary Endpoint
duration of delirium
Status
Terminated
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
May 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • •Pregnancy
  • •M. Parkinson
  • •Lewy-body dementia
  • •Prolonged QT-time
  • •Known allergy to the medicinals used
  • •Renal replacement therapy
  • •Hepatic encephalopathy
  • •Hyperthyroid
  • •Previous suicide attempts
  • •Syndrome of Gilles de la Tourette

Arms & Interventions

2

Methylphenidate

Intervention: Methylphenidate

3

Rivastigmine

Intervention: Rivastigmine

4

Haloperidol

Intervention: Haloperidol

Outcomes

Primary Outcomes

duration of delirium

Time Frame: Days

Secondary Outcomes

  • delirium severity(duration of delirium)
  • frequency of side effects(duration of intervention)
  • duration of ICU-stay(days)
  • duration of in hospital stay(days)

Study Sites (1)

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