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Rivastigmine for delirium in Intensive Care patients, a double-blind, randomised, placebo-controlled, multi-center add-on trial - Rivastigmine for ICU-delirium

Rivastigmine for delirium in Intensive Care patients, a double-blind, randomised, placebo-controlled, multi-center add-on trial - Rivastigmine for ICU-delirium

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-005300-41-NL
Enrollment
Unknown
Registered
2008-02-28
Start date
2008-05-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium MedDRA version: 9.1 Level: LLT Classification code 10012218 Term: Delirium MedDRA version: 9.1 Level: LLT Classification code 10012220 Term: Delirium due to a general medical condition MedDRA version: 9.1 Level: LLT Classification code 10012226 Term: Delirium, cause unknown MedDRA version: 9.1 Level: LLT Classification code 10013758 Term: Drug-induced delirium MedDRA version: 9.1 Level: PT Classification code 10012218 Term: Delirium

Interventions

Trade Name: Exelon Product Name: Exelon Pharmaceutical Form: Oral solution INN or Proposed INN: RIVASTIGMINE CAS Number: 123441032 Pharmaceutical form of the placebo: Oral suspension Route of administ

Sponsors

University Medical Center Utrecht
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years or older 2. Admission at an ICU 3. Positive CAM-ICU Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Known allergy to rivastigmine 2. Unable to receive enteric medication 3. Pregnant or lactating 4. Renal replacement therapy 5. Hepatic encephalopathy 6. Second or third degree atrioventricular block 7. Delirium due to benzodiazepine withdrawal.

Design outcomes

Primary

MeasureTime frame
Main Objective: To study whether rivastigmine is associated with a shorter duration of delirium in ICU patients. ;Secondary Objective: To study whether rivastigmine reduces costs.;Primary end point(s): The primary outcome parameter will be the duration of delirium during hospital admission (i.e. at the ICU and at the ward combined). This will be assessed by the sum of the duration of ICU delirium (defined as the number of hours that the CAM-ICU is positive), and the duration of delirium at a ward with lower level of care (defined as the number of hours that the CAM is positive).—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026