Clinical trial NCT01956604: The Oslo Study of Clonidine in Elderly Patients With Delirium
Official title: The Oslo Study of Clonidine in Elderly Patients With Delirium
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Delirium
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: MDAS (Memorial delirium assessment scale)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
Secondary outcomes:
measure: Time-to-first delirium
timeFrame: 2 weeks
measure: Incidence of "full-scale" delirium
timeFrame: 2 weeks
measure: Severity of delirium
timeFrame: 2 weeks
measure: Delirium subtype
timeFrame: 2 weeks
measure: The use of "rescue medication"
timeFrame: 2 weeks
measure: Length of hospital stay
timeFrame: Hospital stay
measure: Patient distress
timeFrame: 2 weeks
measure: Side effects of clonidine
timeFrame: 4 months
measure: Pharmacokinetic response to clonidine
timeFrame: 1 week
measure: Pharmacodynamic response to clonidine
timeFrame: 2 weeks
measure: Biomarkers
timeFrame: 2 weeks
measure: Institutionalization
timeFrame: 4 months
measure: Survival
timeFrame: 4 months
measure: Cognitive function/ independence
timeFrame: 4 months
Other outcomes:
measure: Exposure-response analyses
timeFrame: 4 months
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Torgeir Bruun Wyller, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hov KR, Neerland BE, Andersen AM, Undseth O, Wyller VB, MacLullich AMJ, Skovlund E, Qvigstad E, Wyller TB. The use of clonidine in elderly patients with delirium; pharmacokinetics and hemodynamic responses. BMC Pharmacol Toxicol. 2018 Jun 8;19(1):29. doi: 10.1186/s40360-018-0218-1.
citation: Neerland BE, Hov KR, Bruun Wyller V, Qvigstad E, Skovlund E, MacLullich AM, Bruun Wyller T. The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial. BMC Geriatr. 2015 Feb 10;15:7. doi: 10.1186/s12877-015-0006-3.