The Oslo Study of Clonidine in Elderly Patients With Delirium

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-10

Study Completion Date

2017-09-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Clonidine

Clonidine administered orally:

Day 1/loading doses: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.

Group Type EXPERIMENTAL

Clonidine

Intervention Type DRUG

Placebo (sugar pill)

Placebo administered orally (identical capsula as for expirimental drug):

Day 1/loading doases: 75µg every 3rd hour until maximum 4 doses. Day 2-7/maintenance doses: 75µg BID. Duration of treatment is maximum 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Clonidine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No