Delirium in elderly patients admitted to the acute geriatric ward
Conditions
Interventions
Trade Name: Catapresan
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following conditions must apply to the prospective patient at screening prior to receiving study agent: • Patient admitted to the acute, medical, geriatric ward • Delirium or subsyndromal delirium diagnosed with CAM / MDAS within the last 48 hours •Signed informed consent from patient or relatives and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/ local regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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 100
Exclusion criteria
Exclusion criteria: • Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree AV-block or any other reason causing HR <50 bpm at time of inclusion. • Symptomatic hypotension or ortostatic hypotension, or a systolic BP <120 at the time of inclusion (after adequate rehydration). • Reduced cerebral and/ or peripheral circulation due to vessel disease (ie manifest stroke within the last 3 months or critical peripheral ischemia). • A diagnosis of polyneuropathy. • Pheochromocytoma. • Renal insufficiency (estimated GFR<30 ml/min according to the MDRD formula). • Considered as moribund at admittance. • Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin • Previously included in this study • Adverse reactions to clonidine or excipients (lactose, saccharose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium symptoms (measured by MDAS scores) in patients diagnosed with DSM-IV delirium (diagnosed by CAM).;Secondary Objective: We will study the feasibility of oral clonidine in a geriatric ward and effects of clonidine upon a variety of outcomes as a means to design a more definite study later. ;Primary end point(s): Trajectory of delirium (severity and duration) measured by CAM and MDAS;Timepoint(s) of evaluation of this end point: At discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We will compare the actively treated group with the placebo group (also with subanalyses for subsyndromal delirium and hypoactive/hyperactive/mixed delirium) with respect to: • Incidence of “full-scale” delirium, measured by CAM • Severity of delirium, measured by MDAS • Time-to-first delirium resolution • Delirium subtype, measured by MDAS • The use of “rescue medication”, as other sedatives, analgetics and antipsychotics • Length of hospital stay • Side effects of clonidine • Pharmacokinetic/ pharmacodynamic response to clonidine • Biomarkers • Institutionalization • Survival • Cognitive function/ independence in follow-up after 4 months;Timepoint(s) of evaluation of this end point: At discharge for hospital and 4 months after discharge from hospital | — |
Countries
Norway
Contacts
Public ContactDepartment of Geriatric medicine, O
Oslo University Hospital
Outcome results
None listed