The Oslo Study of Clonidine in Elderly Patients With Delirium
Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delirium
Intervention: Clonidine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Oslo University Hospital Official(s) and/or principal investigator(s): Torgeir Bruun Wyller, MD PhD, Principal Investigator, Affiliation: Oslo University Hospital
Overall contact: Torgeir Bruun Wyller, MD PhD, Phone: +47 91166682, Email: t.b.wyller@medisin.uio.no
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: MDAS (Memorial delirium assessment scale)
Secondary outcome: Time-to-first deliriumIncidence of "full-scale" delirium Severity of delirium Delirium subtype The use of "rescue medication" Length of hospital stay Patient distress Side effects of clonidine Pharmacokinetic response to clonidine Pharmacodynamic response to clonidine Biomarkers Institutionalization Survival Cognitive function/ independence
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Torgeir Bruun Wyller, MD PhD, Phone: +47 91166682, Email: t.b.wyller@medisin.uio.no
Oslo University Hospital, Oslo N-0424, Norway; Recruiting Bruun Wyller, Email: t.b.wyller@medisin.uio.no Bjørn Erik Neerland, MD, Sub-Investigator Karen Roksund Hov, MD, Sub-Investigator
Additional Information
Starting date: April 2014
Last updated: January 12, 2015
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