The Oslo Study of Clonidine in Elderly Patients With Delirium

Delirium Clinical Trial

— LUCID  

Official title:

The Oslo Study of Clonidine in Elderly Patients With Delirium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01956604
• Other study ID #: 2013-000815-26
• Secondary ID: 2013-000815-26
• Status: Terminated
• Phase: Phase 2
• Start date: April 10, 2014
• Est. completion date: September 12, 2017

Study information

• Verified date: October 2018
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 12, 2017
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Clonidine

• Placebo

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exposure-response analyses	We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine	4 months
Primary	MDAS (Memorial delirium assessment scale)		Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
Secondary	Time-to-first delirium	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	2 weeks
Secondary	Incidence of "full-scale" delirium	• monitored by DSM-5 criteria	2 weeks
Secondary	Severity of delirium	measured by MDAS, OSLA	2 weeks
Secondary	Delirium subtype	Measured by MDAS, OSLA	2 weeks
Secondary	The use of "rescue medication"		2 weeks
Secondary	Length of hospital stay		Hospital stay
Secondary	Patient distress		2 weeks
Secondary	Side effects of clonidine		4 months
Secondary	Pharmacokinetic response to clonidine		1 week
Secondary	Pharmacodynamic response to clonidine		2 weeks
Secondary	Biomarkers		2 weeks
Secondary	Institutionalization		4 months
Secondary	Survival		4 months
Secondary	Cognitive function/ independence		4 months