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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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