LUCID: The Oslo Study of Clonidine in Elderly Patients With Delirium

Sponsor

Oslo University Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01956604

Collaborator

(none)

Enrollment

Location

Arms

41.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Delirium	Drug: Clonidine Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Oslo Study of Clonidine in Elderly Patients With Delirium

Actual Study Start Date :

Apr 10, 2014

Actual Primary Completion Date :

Sep 12, 2017

Actual Study Completion Date :

Sep 12, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Clonidine
Placebo Comparator: 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.	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 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.

Drug: Clonidine

Placebo Comparator: 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.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

MDAS (Memorial delirium assessment scale) [Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks]

Secondary Outcome Measures

Time-to-first delirium [2 weeks]
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
Incidence of "full-scale" delirium [2 weeks]
• monitored by DSM-5 criteria
Severity of delirium [2 weeks]
measured by MDAS, OSLA
Delirium subtype [2 weeks]
Measured by MDAS, OSLA
The use of "rescue medication" [2 weeks]
Length of hospital stay [Hospital stay]
Patient distress [2 weeks]
Side effects of clonidine [4 months]
Pharmacokinetic response to clonidine [1 week]
Pharmacodynamic response to clonidine [2 weeks]
Biomarkers [2 weeks]
Institutionalization [4 months]
Survival [4 months]
Cognitive function/ independence [4 months]

Other Outcome Measures

Exposure-response analyses [4 months]
We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oslo University Hospital	Oslo		Norway	N-0424

Sponsors and Collaborators

Oslo University Hospital

Investigators

Principal Investigator: Torgeir Bruun Wyller, MD PhD, Oslo University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bjørn Erik Neerland, MD, Medical doctor, PhD student, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT01956604

Other Study ID Numbers:

2013-000815-26
2013-000815-26

First Posted:

Oct 8, 2013

Last Update Posted:

Oct 31, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Delirium

Clonidine

Study Results

No Results Posted as of Oct 31, 2018