Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04742673
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2021-01-29
Brief Title:
Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MENDING
Brief Summary:
This proof-of-concept study examines whether the acute brain dysfunction that occurs in critically ill patients is improved by administration of intravenous guanfacine
Detailed Description:
Delirium during critical illness is to date the primary potentially modifiable risk factor for acquired dementia after critical illness ADRD There are however no Food and Drug Administration FDA approved medications to mitigate delirium Benzodiazepines are ineffective at reducing the incidence or duration of delirium and on the contrary increase the risk Furthermore large randomized controlled studies have shown that antipsychotic agents have no effect vs placebo on delirium duration mechanical ventilation hospital length of stay or death Therefore current clinical practice guidelines no longer recommend routine use of benzodiazepines or antipsychotics for treatment of delirium Despite these recommendations benzodiazepine antipsychotics and other drugs are routinely prescribed to critically ill patients due to the urgent clinical need to control delirium symptoms The alpha-2 agonist dexmedetomidine is the most successful agent for delirium identified to date However it is typically administered as a continuous infusion and requires ICU-level monitoring due to hypotension and bradycardia risks The delirium sparing benefits of dexmedetomidine have been postulated to result from alpha-2 agonist mediated modulation of CNS inflammation microcirculatory blood flow and biomimetic sleep
The alpha-2 agonist guanfacine an FDA-approved medication for use in hypertension and attention deficit hyperactivity disorder has a higher selectivity for the alpha-2A receptor in the central nervous system Thus delirium sparing benefits may be improved with guanfacine while reducing systemic effects Further instead of a continuous infusion the pharmacokinetic and pharmacodynamic properties of guanfacine favor a twice a day bolus dosing schedule This Maximizing trEatment of Neurological Dysfunction using INtravenous Guanfacine MENDING study will investigate the benefits of intravenous IV guanfacine In this phase II proof-of-concept trial of IV guanfacine vs placebo for the treatment of critical illness delirium the following specific aims will be tested in critically ill patients with delirium
Aim 1 To determine whether IV guanfacine will increase the number of days alive without delirium and coma DCFDs over 14 days relative to placebo
Aim 2 To evaluate whether IV guanfacine twice a day will increase days alive and free of mechanical ventilation VFDs and days alive and free of the ICU IFDs over 28 days relative to placebo
Aim 3 To assess whether IV guanfacine can reduce the development of ADRD after critical illness
Identifying a safe and effective treatment for delirium would have exponential benefits to patients families healthcare and society This first study of IV guanfacine builds upon extensive research regarding the benefits of alpha-2 agonists for brain dysfunction
The alpha-2 agonist guanfacine an FDA-approved medication for use in hypertension and attention deficit hyperactivity disorder has a higher selectivity for the alpha-2A receptor in the central nervous system Thus delirium sparing benefits may be improved with guanfacine while reducing systemic effects Further instead of a continuous infusion the pharmacokinetic and pharmacodynamic properties of guanfacine favor a twice a day bolus dosing schedule This Maximizing trEatment of Neurological Dysfunction using INtravenous Guanfacine MENDING study will investigate the benefits of intravenous IV guanfacine In this phase II proof-of-concept trial of IV guanfacine vs placebo for the treatment of critical illness delirium the following specific aims will be tested in critically ill patients with delirium
Aim 1 To determine whether IV guanfacine will increase the number of days alive without delirium and coma DCFDs over 14 days relative to placebo
Aim 2 To evaluate whether IV guanfacine twice a day will increase days alive and free of mechanical ventilation VFDs and days alive and free of the ICU IFDs over 28 days relative to placebo
Aim 3 To assess whether IV guanfacine can reduce the development of ADRD after critical illness
Identifying a safe and effective treatment for delirium would have exponential benefits to patients families healthcare and society This first study of IV guanfacine builds upon extensive research regarding the benefits of alpha-2 agonists for brain dysfunction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3R01AG053582-05S1 | NIH | None | httpsreporternihgovquickSearch3R01AG053582-05S1 |