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The Oslo Study of Clonidine in Elderly Patients With Delirium (LUCID)

Primary Purpose

Delirium

Status
Terminated
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Clonidine
Placebo
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clonidine

Placebo (sugar pill)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

MDAS (Memorial delirium assessment scale)

Secondary Outcome Measures

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
Incidence of "full-scale" delirium
• monitored by DSM-5 criteria
Severity of delirium
measured by MDAS, OSLA
Delirium subtype
Measured by MDAS, OSLA
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

Full Information

First Posted
September 25, 2013
Last Updated
October 29, 2018
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01956604
Brief Title
The Oslo Study of Clonidine in Elderly Patients With Delirium
Acronym
LUCID
Official Title
The Oslo Study of Clonidine in Elderly Patients With Delirium
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
The inclusion rate was too low, due to the exclusion criteria.
Study Start Date
April 10, 2014 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clonidine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (sugar pill)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clonidine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
MDAS (Memorial delirium assessment scale)
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks
Secondary Outcome Measure Information:
Title
Time-to-first delirium
Description
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
Time Frame
2 weeks
Title
Incidence of "full-scale" delirium
Description
• monitored by DSM-5 criteria
Time Frame
2 weeks
Title
Severity of delirium
Description
measured by MDAS, OSLA
Time Frame
2 weeks
Title
Delirium subtype
Description
Measured by MDAS, OSLA
Time Frame
2 weeks
Title
The use of "rescue medication"
Time Frame
2 weeks
Title
Length of hospital stay
Time Frame
Hospital stay
Title
Patient distress
Time Frame
2 weeks
Title
Side effects of clonidine
Time Frame
4 months
Title
Pharmacokinetic response to clonidine
Time Frame
1 week
Title
Pharmacodynamic response to clonidine
Time Frame
2 weeks
Title
Biomarkers
Time Frame
2 weeks
Title
Institutionalization
Time Frame
4 months
Title
Survival
Time Frame
4 months
Title
Cognitive function/ independence
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Exposure-response analyses
Description
We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torgeir Bruun Wyller, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
29884231
Citation
Hov KR, Neerland BE, Andersen AM, Undseth O, Wyller VB, MacLullich AMJ, Skovlund E, Qvigstad E, Wyller TB. The use of clonidine in elderly patients with delirium; pharmacokinetics and hemodynamic responses. BMC Pharmacol Toxicol. 2018 Jun 8;19(1):29. doi: 10.1186/s40360-018-0218-1.
Results Reference
derived
PubMed Identifier
25887557
Citation
Neerland BE, Hov KR, Bruun Wyller V, Qvigstad E, Skovlund E, MacLullich AM, Bruun Wyller T. The protocol of the Oslo Study of Clonidine in Elderly Patients with Delirium; LUCID: a randomised placebo-controlled trial. BMC Geriatr. 2015 Feb 10;15:7. doi: 10.1186/s12877-015-0006-3.
Results Reference
derived

Learn more about this trial

The Oslo Study of Clonidine in Elderly Patients With Delirium

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