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

Condition(s) targeted: Delirium

Intervention: Haloperidol (Drug); Methylphenidate (Drug); Rivastigmine (Drug); No intervention (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Jozef Kesecioglu, MD PhD, Study Director, Affiliation: University Medical Center Utrecht

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.

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

Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Efficacy Study

Primary outcome: duration of delirium

Secondary outcome:

duration of ICU-stay

duration of in hospital stay

delirium severity

frequency of side effects

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Older than 18 years

- Diagnosed as hypoactive delirium

- Informed consent given

Exclusion Criteria:

- 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

University Medical Center, Utrecht 3508 GA, Netherlands

Starting date: February 2008
Ending date: May 2008
Last updated: May 27, 2008