Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648681
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-12
Brief Title:
Lemborexant to Prevent Post-operative Delirium in Cardiac Surgery Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Trial of Lemborexant for the Prevention of Delirium After Cardiac Surgery PROTEX A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROTEX
Brief Summary:
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality Currently there are no drug therapies to prevent delirium Orexin is a neuromodulator thought to play an important role in disordered sleep one of the instigators of delirium Lembrorexant is an orexin antagonist originally approved for sleep that may also reduce the incidence of delirium The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium and improving sleep
Detailed Description:
Purpose
This is a pilot study to determine the feasibility of a larger randomized controlled trial comparing lemborexant to placebo in patients following cardiac surgery The primary outcome of this feasibility study is to determine the rate of enrolment adherence and retention of patients Secondary outcomes will include incidence of postoperative delirium delirium free days quality of sleep hospital length of stay and the safety and adverse side effect profile of Lemborexant
Hypothesis
1 Primary outcome It is feasible to perform a study of lembrorexant versus placebo in patients after cardiac surgery as defined by achieving a recruitment rate of at least 70 and adherence rate of 80 to the study protocol and drug administration schedule
Justification
Postoperative delirium is a frequent complication after cardiac surgery with an incidence estimated at 20-52 It is associated with increased 1 year mortality longer ICU and hospital length of stay and declines in functional and cognitive status that may persist for up to one year Orexin a neuromodulator regulating sleep and wakefulness is believed to significantly influence the pathophysiology of delirium through its association with disordered sleep Thus far there are no promising therapies in prevention or treatment of post cardiac surgery delirium
Lemborexant is a novel orexin antagonist that has been approved for treating insomnia and has shown promising results in some studies in reducing incidence of delirium post-cardiac surgery However the generalizability of these studies is limited by small numbers of patients an exclusively Asian population variability in clinical settings use of different clinical delirium assessment tools and variability in comparator groups In addition the safety profile of lembrorexant has not been well established in the cardiac surgery population
Objectives
Primary Objective to determine the rate of enrolment adherence and retention of patients in a randomized controlled trial comparing Lemborexant to placebo early after cardiac surgery
Secondary Objective to compare the incidence of postoperative delirium quality of sleep as measured by Richard Campbells Sleep Questionnaire RCSQ delirium free days hospital length of stay between Lembrorexant and placebo To determine the safety and adverse side effect profile of Lemborexant
Research Design
This will be a single centre randomized double blinded placebo-controlled pilot trial with 11 allocation of study drug to placebo Local enrollment local is 60 patients 30 control 30 experimental
Statistical Analysis plan
Patient characteristics will be described using means and standard deviations for continuous data and proportions for categorical data All analyses will be conducted on the intention-to-treat population For the primary feasibility outcomes the investigators will calculate 95 confidence intervals using the whole trial sample For the secondary outcomes the investigators will compare proportions with Lembrorexant vs placebo two-sample t-test for parametric data and Wilcoxon Rank Sum test for non parametric data Analyses will be conducted using R 405
Sample Size Calculation To assess feasibility outcomes the sample size was calculated to estimate an adherence rate of 80 with a 95 confidence interval of - 10 From this calculation the sample size will be set at 60 participants or 10 of the sample size of a definitive trial
This is a pilot study to determine the feasibility of a larger randomized controlled trial comparing lemborexant to placebo in patients following cardiac surgery The primary outcome of this feasibility study is to determine the rate of enrolment adherence and retention of patients Secondary outcomes will include incidence of postoperative delirium delirium free days quality of sleep hospital length of stay and the safety and adverse side effect profile of Lemborexant
Hypothesis
1 Primary outcome It is feasible to perform a study of lembrorexant versus placebo in patients after cardiac surgery as defined by achieving a recruitment rate of at least 70 and adherence rate of 80 to the study protocol and drug administration schedule
Justification
Postoperative delirium is a frequent complication after cardiac surgery with an incidence estimated at 20-52 It is associated with increased 1 year mortality longer ICU and hospital length of stay and declines in functional and cognitive status that may persist for up to one year Orexin a neuromodulator regulating sleep and wakefulness is believed to significantly influence the pathophysiology of delirium through its association with disordered sleep Thus far there are no promising therapies in prevention or treatment of post cardiac surgery delirium
Lemborexant is a novel orexin antagonist that has been approved for treating insomnia and has shown promising results in some studies in reducing incidence of delirium post-cardiac surgery However the generalizability of these studies is limited by small numbers of patients an exclusively Asian population variability in clinical settings use of different clinical delirium assessment tools and variability in comparator groups In addition the safety profile of lembrorexant has not been well established in the cardiac surgery population
Objectives
Primary Objective to determine the rate of enrolment adherence and retention of patients in a randomized controlled trial comparing Lemborexant to placebo early after cardiac surgery
Secondary Objective to compare the incidence of postoperative delirium quality of sleep as measured by Richard Campbells Sleep Questionnaire RCSQ delirium free days hospital length of stay between Lembrorexant and placebo To determine the safety and adverse side effect profile of Lemborexant
Research Design
This will be a single centre randomized double blinded placebo-controlled pilot trial with 11 allocation of study drug to placebo Local enrollment local is 60 patients 30 control 30 experimental
Statistical Analysis plan
Patient characteristics will be described using means and standard deviations for continuous data and proportions for categorical data All analyses will be conducted on the intention-to-treat population For the primary feasibility outcomes the investigators will calculate 95 confidence intervals using the whole trial sample For the secondary outcomes the investigators will compare proportions with Lembrorexant vs placebo two-sample t-test for parametric data and Wilcoxon Rank Sum test for non parametric data Analyses will be conducted using R 405
Sample Size Calculation To assess feasibility outcomes the sample size was calculated to estimate an adherence rate of 80 with a 95 confidence interval of - 10 From this calculation the sample size will be set at 60 participants or 10 of the sample size of a definitive trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None