NCT01956604

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

April 10, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

3.4 years

First QC Date

September 25, 2013

Last Update Submit

October 29, 2018

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • MDAS (Memorial delirium assessment scale)

    Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks

Secondary Outcomes (14)

  • Time-to-first delirium

    2 weeks

  • Incidence of "full-scale" delirium

    2 weeks

  • Severity of delirium

    2 weeks

  • Delirium subtype

    2 weeks

  • The use of "rescue medication"

    2 weeks

  • +9 more secondary outcomes

Other Outcomes (1)

  • Exposure-response analyses

    4 months

Study Arms (2)

Clonidine

EXPERIMENTAL

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 (sugar pill)

PLACEBO COMPARATOR

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

Interventions

ClonidineDRUG
Clonidine
PlaceboDRUG
Placebo (sugar pill)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, N-0424, Norway

Location

Related Publications (2)

  • 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.

    PMID: 29884231DERIVED

  • 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.

    PMID: 25887557DERIVED

MeSH Terms

Conditions

Delirium

Interventions

Clonidine

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Torgeir Bruun Wyller, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor, PhD student

Study Record Dates

First Submitted

September 25, 2013

First Posted

October 8, 2013

Study Start

April 10, 2014

Primary Completion

September 12, 2017

Study Completion

September 12, 2017

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

NO(1)