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

• Sponsor: UMC Utrecht (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00599287
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 27.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: Haloperidol; Drug: Methylphenidate; Drug: Rivastigmine	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients: a Randomized, Mono-blind Pilot Trial
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 No intervention
Experimental: 2 Methylphenidate	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; Other Names: Ritalin
Experimental: 3 Rivastigmine	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; Other Names: Exelon
Experimental: 4 Haloperidol	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); Other Names: Haldol

Outcome Measures

Primary Outcome Measures

1. duration of delirium [Days]

Secondary Outcome Measures

1. duration of ICU-stay [days]

2. duration of in hospital stay [days]

3. delirium severity [duration of delirium]

4. frequency of side effects [duration of intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Older than 18 years

• Diagnosed as hypoactive delirium

• Informed consent given

Exclusion Criteria:

• Pregnancy

• Epilepsy

• 1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center	Utrecht		Netherlands	3508 GA

Sponsors and Collaborators

• UMC Utrecht

Investigators

• Study Director: Jozef Kesecioglu, MD PhD, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00599287
• Other Study ID Numbers: ICHYPDEL/002; METC-UMCU 07/236
• First Posted: Jan 23, 2008
• Last Update Posted: Mar 21, 2018
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: ICU delirium; Hypoactive delirium; Haloperidol; Methylphenidate; Rivastigmine; Hypoactive ICU delirium
• Additional relevant MeSH terms: Delirium; Hypokinesia; Haloperidol; Haloperidol decanoate; Methylphenidate; Rivastigmine

Study Results

No Results Posted as of Mar 21, 2018