Delirium
Conditions
Brief summary
Delirium (acute confusional state)is characterized by an acute decline in attention and cognition, and is a common clinical syndrome in elderly patients. The purpose of this randomised, controlled, parallel group pilot trial is to explore superiority of clonidine vs placebo in decreasing delirium in patients diagnosed delirium at the acute geriatric ward. We will also 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.
Interventions
DRUGClonidine
DRUGPlacebo
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient \> 65 years old admitted to the Medical department * Delirium or subsyndromal delirium diagnosed within the last 48 hours * Signed informed consent from patient or relatives * Expected cooperation of the patients for the treatment and follow up
Exclusion criteria
* Symptomatic bradycardia, bradycardia due to sick-sinus-syndrome, second- or third- degree AV-block (not treated With pacemaker) or any other reason causing HR \<50 bpm at time of inclusion * Symptomatic hypotension or orthostatic hypotension, or a systolic BP \<120 at the time of inclusion * Ischemic stroke within the last 3 months or critical peripheral ischemia * Acute coronary syndrome, unstable or severe coronary heart disease (symptoms at minimal physical activity; NYHA 3 and 4) and moderate to severe heart failure (NYHA 3 and 4). * A diagnosis of polyneuropathy or pheochromocytoma * Renal insufficiency (estimated GFR\<30 ml/min according to the MDRD formula). * Body weight \< 45 kg. * Considered as moribund on admission. * Not able to take oral medications * Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin * Previously included in this study * Adverse reactions to clonidine or excipients (lactose, saccharose) * Not speaking or reading Norwegian * Any other condition as evaluated by the treating physician * Admitted to the ICU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MDAS (Memorial delirium assessment scale) | Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of full-scale delirium | 2 weeks | • monitored by DSM-5 criteria |
| Severity of delirium | 2 weeks | measured by MDAS, OSLA |
| Delirium subtype | 2 weeks | Measured by MDAS, OSLA |
| The use of rescue medication | 2 weeks | — |
| Length of hospital stay | Hospital stay | — |
| Patient distress | 2 weeks | — |
| Side effects of clonidine | 4 months | — |
| Time-to-first delirium | 2 weeks | 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: • time to first resolution, monitored by DSM-5 criteria |
| Pharmacodynamic response to clonidine | 2 weeks | — |
| Biomarkers | 2 weeks | — |
| Institutionalization | 4 months | — |
| Survival | 4 months | — |
| Cognitive function/ independence | 4 months | — |
| Pharmacokinetic response to clonidine | 1 week | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exposure-response analyses | 4 months | We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine |
Countries
Norway
Outcome results
None listed