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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00599287
• Other study ID #: ICHYPDEL/002
• Secondary ID: METC-UMCU 07/236
• Status: Terminated
• Phase: Phase 3
• First received: January 10, 2008
• Last updated: March 19, 2018
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: February 2008
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Hypokinesia

Intervention

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)
• 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
• 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

Locations

Country	Name	City	State
Netherlands	University Medical Center	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of delirium		Days
Secondary	duration of ICU-stay		days
Secondary	duration of in hospital stay		days
Secondary	delirium severity		duration of delirium
Secondary	frequency of side effects		duration of intervention