Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000815-26 | EudraCT Number |
Not provided
Not provided
The inclusion rate was too low, due to the exclusion criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonidine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| MDAS (Memorial delirium assessment scale) | Participants will be followed for the duration of hospital stay, an expected average of approximately 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 weeks |
| Incidence of "full-scale" delirium |
| Measure | Description | Time Frame |
|---|---|---|
| Exposure-response analyses | We will also do per protocol analyses and exposure-response analyses based on measurements of the plasma concentration of clonidine | 4 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torgeir Bruun Wyller, MD PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | N-0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29884231 | Derived | 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. | |
| 25887557 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
• monitored by DSM-5 criteria |
| 2 weeks |
| Severity of delirium | measured by MDAS, OSLA | 2 weeks |
| Delirium subtype | Measured by MDAS, OSLA | 2 weeks |
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |