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

Phase 3

Completed

Conditions: agitation
ICU-pyschosis
ICU-syndrome
10012221

Registration Number: NL-OMON33892

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 440

Inclusion Criteria

1. 18 years or older
2. Positive CAM-ICU
3. Anticipated ICU and/or Medium Care length of stay >48 hours

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. Uncertainty about diagnosis delirium and no confirmation by neurologist, psychiatrist or geriatrician
8. Bradycardia with hemodynamic consequences (without functioning pacemaker)
9. No informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Duration of delirium during hospital admission (i.e. at the ICU and at the ward<br /><br>combined). This will be assessed by the sum of the duration of ICU delirium<br /><br>(defined as the number of hours that the CAM-ICU is positive), and the duration<br /><br>of delirium at a ward with lower level of care (defined as the number of hours<br /><br>that the CAM is positive). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Severity of delirium as assessed with the DSI. 2. The number of times rescue<br /><br>medication is given in case of severe agitation, as well as the total dose of<br /><br>haloperidol and propofol. 3. The number and type of accidentally removed<br /><br>catheters. 4. Use of physical restraints. 5. Frequency and distribution of<br /><br>possible adverse effects. 6. Length of ICU stay.<br /><br>7. The number of re-admissions to the ICU during hospital stay. 8. Length of<br /><br>hospital stay.<br /><br>9. Cumulative survival from inclusion in the trial until 90 days. 10.<br /><br>Activities of daily living 90 days after inclusion in the trial. 11. Quality of<br /><br>life 90 days after inclusion in the proposed study. 12. Cognitive function 90<br /><br>days after inclusion in the trial.</p><br>