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

NCT00599287 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-03-21

No results posted yet for this study

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

Interventions

DRUG

Haloperidol

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)

DRUG

Methylphenidate

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

DRUG

Rivastigmine

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

Sponsors & Collaborators

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Jozef Kesecioglu, MD PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599287 on ClinicalTrials.gov