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Trial record 55 of 326 for:    clonidine

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

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ClinicalTrials.gov Identifier: NCT01956604
Recruitment Status : Terminated (The inclusion rate was too low, due to the exclusion criteria.)
First Posted : October 8, 2013
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
Bjørn Erik Neerland, MD, Oslo University Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : April 10, 2014
Actual Primary Completion Date : September 12, 2017
Actual Study Completion Date : September 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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



Primary Outcome Measures :
  1. 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 Measures :
  1. Time-to-first delirium [ Time Frame: 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


  2. Incidence of "full-scale" delirium [ Time Frame: 2 weeks ]
    • monitored by DSM-5 criteria

  3. Severity of delirium [ Time Frame: 2 weeks ]
    measured by MDAS, OSLA

  4. Delirium subtype [ Time Frame: 2 weeks ]
    Measured by MDAS, OSLA

  5. The use of "rescue medication" [ Time Frame: 2 weeks ]
  6. Length of hospital stay [ Time Frame: Hospital stay ]
  7. Patient distress [ Time Frame: 2 weeks ]
  8. Side effects of clonidine [ Time Frame: 4 months ]
  9. Pharmacokinetic response to clonidine [ Time Frame: 1 week ]
  10. Pharmacodynamic response to clonidine [ Time Frame: 2 weeks ]
  11. Biomarkers [ Time Frame: 2 weeks ]
  12. Institutionalization [ Time Frame: 4 months ]
  13. Survival [ Time Frame: 4 months ]
  14. Cognitive function/ independence [ Time Frame: 4 months ]

Other Outcome Measures:
  1. Exposure-response analyses [ Time Frame: 4 months ]
    We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956604


Locations
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Norway
Oslo University Hospital
Oslo, Norway, N-0424
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Torgeir Bruun Wyller, MD PhD Oslo University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bjørn Erik Neerland, MD, Medical doctor, PhD student, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01956604     History of Changes
Other Study ID Numbers: 2013-000815-26
2013-000815-26 ( EudraCT Number )
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Clonidine
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action